Siemens Healthineers
Country not established
- Devices
- 10
What Siemens Healthineers makes
Siemens Healthineers manufactures diagnostic ultrasound systems, including the ACUSON S3000 and S2000, which are used for imaging internal body structures. They also produce Symbia SPECT and SPECT/CT systems, designed for nuclear imaging and combined computed tomography to assess organ function and anatomy.
These devices fall under Class II regulation in the US, with authorisation obtained through the FDA’s 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
ACUSON S3000, S2000 Diagnostic Ultrasound System Ref K183575
Regimes: 510(k) Registry: 510(k)Symbia SPECT and SPECT/CT Systems Ref K241898
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Siemens Healthineers have in the registry?
The registry currently lists 10 devices for Siemens Healthineers. Devices recorded under merged duplicate company entries are counted once.
Which registries list Siemens Healthineers's devices?
Among its 10 most recently registered devices, Siemens Healthineers has devices listed in EUDAMED (8 devices), FDA 510(k) (2 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Siemens Healthineers's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Siemens Healthineers's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Siemens Healthineers in the registry?
The most recently registered devices listed for Siemens Healthineers include SOMATOM X.cite 11330001, MAGNETOM Altea 11344915, System SOMATOM X.ceed 11330002 and MAGNETOM Lumina 11516153.