Skip to content

Siemens Medical Systems USA, Inc.

Also registered as Siemens Medical Systems USA, Siemens Medical Systems, Inc.

United StatesFDA applicant, unverified

Devices
28
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Siemens Medical Systems USA, Inc. makes

Siemens Medical Systems USA, Inc. manufactures C-arm imaging systems, including the Cios Alpha and Cios Spin models, which are used for surgical imaging and fluoroscopy.

The company's devices are classified as Class II and listed in the FDA 510(k) registry. Siemens Medical Systems USA, Inc. is based in the US.

AI-generated from registry data, 26 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue28

Newest first, rows 1-28 of 28

Search and filter all 28 devices
Skip device list

  • Dynact Ref K042646

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Omnia X/Xs Ultrasound System Ref K020353

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Project P30L Ref K040577

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 6 Channel Body Coil Ref K023571

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Spirit Ref K042328

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom P30 Ct Systems Ref K013522

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Definition Edge Ref K120579

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Leonardo Ref K040970

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Syngo Single Source Dual Engery Ref K122909

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Admire Ref K133646

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Definition Ref K122471

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Definition As Open Ref K130901

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Magnetom Trio System Ref K013586

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Definition Flash Ref K121072

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axiom Sireskop Sd Ref K051602 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Emotion 6 Ct Systems Ref K023687

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Definition Ref K052216

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axiom Artis U Ref K040675

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Syngo.mr Onco, Syngo.mr 3D Lesion Segmentation, Syngo.mr Onco Engine Ref K111861

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Syngo.ct Neuro Perfusion Ref K123541

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axiom Aristos Fx (Multi Purpose Radiography System) Ref K013826

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Somatom Definition Flash Ref K113342

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Syngo Ct Pulmo 3D Ref K123540

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Newcor Ref K020440

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cios Alpha Ref K181560

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Siremobil Iso-C 3D Ref K040347

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mobilette Xp And Mobilett Xphybrid Ref K033238

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cios Spin Ref K210054 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-28 of 28

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2002

    • 27 Nov 2002 Z-0493-03 Unclassified (pre-2012) Terminated There is unintended system movement or unwanted automatic movement of the tabletop. Distribution: Product was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were…
      Full distribution text Product was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Slovakia, Hungary, Ukraine, Russia, Turkmenistan, South Africa, Canada, Malaysia, Japan, and Taiwan.
      Submission number: K923049
    • 5 Aug 2002 Z-0347-03 Unclassified (pre-2012) Terminated Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked. Distribution: The device was distributed to Hospitals nationwide. Submission number: K010721
    • 10 Jul 2002 Z-0322-03 Unclassified (pre-2012) Terminated Head holder cannot be properly secured on the table top. Distribution: The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175…
      Full distribution text The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.
      Submission number: K013522

Frequently asked questions

How many devices does Siemens Medical Systems USA, Inc. have in the registry?

The registry currently lists 28 devices for Siemens Medical Systems USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Siemens Medical Systems USA, Inc.'s devices?

Among its 28 most recently registered devices, Siemens Medical Systems USA, Inc. has devices listed in FDA 510(k) (28 devices).

What risk classes do Siemens Medical Systems USA, Inc.'s devices fall under?

Among its 28 most recently registered devices, the classes recorded for Siemens Medical Systems USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Siemens Medical Systems USA, Inc.?

FDA recall records list 3 recalls initiated by Siemens Medical Systems USA, Inc., the most recent initiated on 27 Nov 2002. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Siemens Medical Systems USA, Inc. in the registry?

The most recently registered devices listed for Siemens Medical Systems USA, Inc. include DYNACT, OMNIA X/XS ULTRASOUND SYSTEM, SOMATOM PROJECT P30L and 6 CHANNEL BODY COIL.

Generated automatically from registry data and not verified by a human reviewer.