Home / 510(k) Clearances / K100102

510(k) K100102

CS-SERIES-FP by Omega Medical Imaging, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2010
Date Received
January 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Omega Medical Imaging, Inc.

  • K242488 — Soteria E-View (January 6, 2025)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212336 — Soteria.AI (November 17, 2021)
  • K191713 — CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroS (October 4, 2019)
  • K182834 — CS-series-FP with Optional ROI Accessory CA-100S (March 29, 2019)
  • K171755 — CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy Sys (February 9, 2018)
  • K121293 — CS-SERIES-FP WITH 3030+OPTION (July 26, 2012)
  • K093572 — R650 QDASM COLLIMATOR (February 3, 2010)
  • K070834 — CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) (May 18, 2007)
  • K062647 — E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 (October 20, 2006)

Other clearances for product code OWB

  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)