<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04056869950143</udiDi>
    <basicUdiDi>0405686900137UX</basicUdiDi>
    <tradeName>syngo.MM Oncology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Medical Solutions USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016485</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11431557</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:47:01.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869950174</udiDi>
    <basicUdiDi>0405686900137UX</basicUdiDi>
    <tradeName>syngo.MI General</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Medical Solutions USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016485</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11431560</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:47:01.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00854904006015</udiDi>
    <basicUdiDi>0854904006HCUSCV6Z</basicUdiDi>
    <tradeName>Synapse CV</tradeName>
    <deviceName>Synapse CV</deviceName>
    <manufacturerName>FUJIFILM Healthcare Americas Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009244</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Synapse CV</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:40:45.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>00854904006008</udiDi>
    <basicUdiDi>0854904006HCUSPACSWY</basicUdiDi>
    <tradeName>Synapse PACS</tradeName>
    <deviceName>Synapse PACS</deviceName>
    <manufacturerName>FUJIFILM Healthcare Americas Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009244</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Synapse PACS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:40:43.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853341006701</udiDi>
    <basicUdiDi>0853341006FFRCTSW</basicUdiDi>
    <tradeName>00853341006701</tradeName>
    <deviceName>Heartflow Analysis</deviceName>
    <manufacturerName>HeartFlow, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020729</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heartflow Analysis v4.x</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:50.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025268202</udiDi>
    <basicUdiDi>0850025268VitreaAVES</basicUdiDi>
    <tradeName>Vitrea</tradeName>
    <deviceName>Vitrea Advanced Visualization</deviceName>
    <manufacturerName>Canon Medical Informatics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020013</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.15.7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:57.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063023203</udiDi>
    <basicUdiDi>081606302LMN22SYSEL</basicUdiDi>
    <tradeName>iTero Lumina PC cfg</tradeName>
    <deviceName>iTero Lumina – PC cfg</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-PR-000047276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:20:35.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063023050</udiDi>
    <basicUdiDi>081606302LMNSCNUEV</basicUdiDi>
    <tradeName>iTero Lumina - PC cfg  intraoral scanning unit</tradeName>
    <deviceName>iTero Lumina PC cfg Intraoral Scanning Unit</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:20:28.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063021414</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Cart Configuration</tradeName>
    <deviceName>iTero Lumina System</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213782</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:20:08.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020493</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D</tradeName>
    <deviceName>iTero Element 5D Family</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205929</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:59.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020288</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element 2</tradeName>
    <deviceName>iTero Element 2 family</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202965</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:54.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814905020328</udiDi>
    <basicUdiDi>081490502VRMDP01KK</basicUdiDi>
    <tradeName>Virtua</tradeName>
    <deviceName>Virtua</deviceName>
    <manufacturerName>Codonics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069099</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Virtua</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:18:39.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615521031572</udiDi>
    <basicUdiDi>0615521GMN1160018M</basicUdiDi>
    <tradeName>Helion</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Videomed Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000024944</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VR401111-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:04:35.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959028630</udiDi>
    <basicUdiDi>0606959BM132LN</basicUdiDi>
    <tradeName>Web, DirectView Software</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069001</emdnCode>
    <emdnDescription>BIOIMAGING PROCESSORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1055635</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:52:31.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151034202</udiDi>
    <basicUdiDi>0405686902381VS</basicUdiDi>
    <tradeName>syngo Dynamics</tradeName>
    <deviceName>MDR_05_IIb_FOR AG S3_syngo Dynamics</deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11708404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:33.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151064551</udiDi>
    <basicUdiDi>0405686902372VR</basicUdiDi>
    <tradeName>Syngo Carbon Space</tradeName>
    <deviceName>MDR_DnA_IIb_SHS_AG_SAMD_SPACE</deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11926807</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:32.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869996172</udiDi>
    <basicUdiDi>0405686902222V5</basicUdiDi>
    <tradeName>AI-Rad Companion (Pulmonary)</tradeName>
    <deviceName>MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>11665780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:06.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869298191</udiDi>
    <basicUdiDi>0405686902009V3</basicUdiDi>
    <tradeName>AI-Rad Companion Prostate MR</tradeName>
    <deviceName>MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>11582981</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:54.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869237626</udiDi>
    <basicUdiDi>0405686901978WU</basicUdiDi>
    <tradeName>syngo.via WebViewer</tradeName>
    <deviceName>MDR_05_FOR_SYNGO_SaMD_IIb</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>11461434</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:49.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869247380</udiDi>
    <basicUdiDi>0405686900137UX</basicUdiDi>
    <tradeName>Modality Viewer VA1</tradeName>
    <deviceName>Image Processing Software_10_IIa_HES</deviceName>
    <manufacturerName>Siemens Medical Solutions USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016485</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:42.376Z</lastUpdated>
  </row>
</eudamedExport>