Cs-Series-Fp
by Omega Medical Imaging, Inc.
510(k) K100102
Cs-Series-Fp is a medical device (FDA Class II; FDA product code OWB, Interventional Fluoroscopic X-Ray System) made by Omega Medical Imaging, Inc., cleared under FDA 510(k) K100102 on 31 Aug 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100102 | Date31 Aug 2010 | StatusActive |
Official records
- FDA 510(k) database K100102
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K100102
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Omega Medical Imaging CS50 | CS50 | 00853901007001 | On the market | |
| Omega Medical Imaging, LLC CS-series-FP | CS-series-FP | 00853901007018 | On the market |
Similar devices
Other devices filed under FDA product code OWB (Interventional Fluoroscopic X-Ray System).
- PS 3000 DIGATAL PHOTOSPOT SYSTEM by Precise Optics
- Virtual C DRF Digital Imaging System by Portavision Medical, LLC
- OEC FLUOROTRAK 9800 PLUS by GE OEC MEDICAL SYSTEMS, INC
- Cios Alpha 11105200 by Siemens Healthcare GmbH
- INNOVA 2100 by GE Medical Systems, LLC
- Ultimax-i, DREX-UI80 V1.60 by Toshiba Medical Systems
- Infinix INFX-8000V, V6.40 by Toshiba Medical Systems Coroporation
- O-arm O2 Imaging System by MEDTRONIC, INC.
- ALLURA XPER FD20 by Philips Medical Systems North America, Inc.
- Azurion R2.0 by Philips Medical Systems Nederland B.V.