StentBoost Mobile
StentBoost Mobile (718160) is a medical device (FDA Class II) made by Philips India Limited, listed in FDA GUDID since 15 Jun 2021 (UDI-DI 00884838103450), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00884838103450 | Date15 Jun 2021 | StatusListed |
Official records
- AccessGUDID record 00884838103450
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Cardiovascular fluoroscopy/intravascular imaging software
- Model / Ref / Catalog
- StentBoost Mobile, 718160
- Primary DI / UDI-DI
- 00884838103450
- FDA product code
- OWB, LLZ
- GMDN term
- Cardiovascular fluoroscopy/intravascular imaging software
- Device class
- Class II
- Regulation number
- 892.1650, 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OWB (Interventional Fluoroscopic X-Ray System).
- ControlRad Select Model Z by Controlrad, Inc.
- I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) by INFIMED, INC.
- ARTIS icono (VE21) System by SIEMENS MEDICAL SOLUTIONS USA, INC.
- RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM by Sigma Vision, Inc.
- INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V by Toshiba America Medical Systems, In.C
- NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM by INFIMED, INC.
- Loop-X 1 P04-2 by medPhoton GmbH
- INNOVA 4100 by GE MEDICAL SYSTEMS, INC.
- SKIN DOSE MONITOR by Mcmahon Medical
- CIOS SELECT 11515055 by Siemens Shanghai Medical Equipment Ltd.