Siemens Ultrasound, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Siemens Ultrasound, Inc. makes
Siemens Ultrasound, Inc. manufactures ultrasound systems and transducers for obstetrics/gynecology (OB/GYN), ear/nose/throat (ENT), dental, and intraluminal imaging. Their portfolio includes handheld and portable ultrasound devices like the Sonoline SI-450 and SI-400, as well as specialized transesophageal echo (TEE) probes for adult and pediatric use. The company also produces intraluminal ultrasound (ILUS) systems for vascular and gastrointestinal applications.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, where they comply with applicable medical device standards. No additional regulatory bodies or international listings are referenced in the provided data.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Sonoline Cf Ref K891449
Regimes: 510(k) Registry: 510(k)Siemens Transesophageal Echo Tee Transducer Ref K891238
Regimes: 510(k) Registry: 510(k)Siemens Si-400 Ref K914013
Regimes: 510(k) Registry: 510(k)Si-1200 / Ilus Ref K911200
Regimes: 510(k) Registry: 510(k)Si-450/Ilus (Intraluminal Ultrasound) Ref K912361
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Siemens Ultrasound, Inc. have in the registry?
The registry currently lists 8 devices for Siemens Ultrasound, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Siemens Ultrasound, Inc.'s devices?
Among its 8 most recently registered devices, Siemens Ultrasound, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Siemens Ultrasound, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Siemens Ultrasound, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Siemens Ultrasound, Inc. in the registry?
The most recently registered devices listed for Siemens Ultrasound, Inc. include SIEMENS SONOLINE SI-450, OB/GYN, ENT, DENTAL DEVICES, SONOLINE CF, SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER and SIEMENS SI-400.