510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Siemens Healthineers AG

RUDOLSTADT Thuringia, DE

Siemens Healthineers AG appears in FDA device records in RUDOLSTADT Thuringia, DE. FDA records list 7 510(k) clearances between and , no PMA records and 6 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
3
Registered establishments
6

FDA records under these names

1 name

FDA records resolved to Siemens Healthineers AG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Siemens AG/Siemens Healthcare GmbHenforcement report, recall

510(k) clearance history

FDA records hold 7 510(k) clearances for Siemens Healthineers AG between 2019 and 2026. The busiest year on record is 2026, with 3. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Siemens Healthineers AG, by decision year
YearClearances
20191
20241
20252
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNHSubstantially Equivalent
K253690LungMapsQIHSubstantially Equivalent
K253023BIOGRAPH OneOUOSubstantially Equivalent
K253495syngo.MR Applications (VB80)LLZSubstantially Equivalent
K251059Syngo Carbon Clinicals (VA41)QIHSubstantially Equivalent
K241898Symbia SPECT and SPECT/CT SystemsKPSSubstantially Equivalent
K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Siemens Healthineers AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30002753993000275399Siemens Healthineers AGRONTGENSTRASSE 2, RUDOLSTADT Thuringia 07407 DE2026
30024660183002466018Siemens Healthineers AGROENTGENSTRASSE 19-21, KEMNATH Bavaria 95478 DE2026
30028081573002808157Siemens Healthineers AGAllee am Rothelheimpark 2, ERLANGEN Bavaria 91052 DE2026and 10 more, listed in full below
30049773353004977335Siemens Healthineers AGSIEMENSSTRASSE 1 -OR-, FORCHHEIM Bavaria 91301 DE2026and 35 more, listed in full below
30026193373002619337Siemens Healthineers Ltd.6 & 7 FI., Bundang First Tower, SEONGNAM-SI Gyeonggi 13591 KR2026
30069851473006985147Siemens Healthineers Ltd.2nd, 3rd and 4th Venture Building, Pohang-si Gyeongbuk 37668 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2242-2024ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.Class IIOpen, Classified
Z-2241-2024ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.Class IIOpen, Classified
Z-2240-2024ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain