Sentinelle Medical, Inc.
CanadaFDA applicant, unverified
- Devices
- 5
What Sentinelle Medical, Inc. makes
Sentinelle Medical, Inc. manufactures MRI-compatible coil arrays and auxiliary patient tables designed for specific imaging applications. Their products include the Sentinel Endo Coil Array for pelvic imaging, the Vanguard Breast MRI Auxiliary Table with 16-channel coil arrays for GE 3T MRI systems, and Vanguard MRI Auxiliary Tables with 4- and 8-channel coil arrays for GE Signa systems. The company also provides navigation systems, such as the Aegis Navigation and Aegis Pelvic Application, for targeted imaging procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Sentinelle Endo Coil Array For Pelvic Imaging Ref K103274
Regimes: 510(k) Registry: 510(k)Aegis Navigation Anda Egis Pelvic Application Ref K093672
Regimes: 510(k) Registry: 510(k)Vanguard Breast Mri Auxiliary Table With 16 Channel Coil Array For Ge 3T Mri System, Model 4000451-51 Ref K100113
Regimes: 510(k) Registry: 510(k)Vanguard Mri Auxiliary Patient Table With 4 And 8 Channel Coil Array For Ge Signa Systems Ref K060873
Regimes: 510(k) Registry: 510(k)Aegis Ref K070244
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sentinelle Medical, Inc. have in the registry?
The registry currently lists 5 devices for Sentinelle Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sentinelle Medical, Inc.'s devices?
Among its 5 most recently registered devices, Sentinelle Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sentinelle Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sentinelle Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sentinelle Medical, Inc. in the registry?
The most recently registered devices listed for Sentinelle Medical, Inc. include SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING, AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION, VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 and VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS.