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510(k) K093572

R650 QDASM COLLIMATOR by Omega Medical Imaging, Inc. — Product Code IZW

K093572 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, Inc. for the device "R650 QDASM COLLIMATOR". The FDA issued a decision of Substantially Equivalent on February 3, 2010. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Omega Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2010
Date Received
November 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Automatic, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

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)
  • K100102 — CS-SERIES-FP (August 31, 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 IZW

  • K101039 — SHIMADZU COLLIMATOR R-300 (September 20, 2010)
  • K090578 — SHIMADZU COLLIMATOR R-30H (November 6, 2009)
  • K091517 — RALCO, MODEL R225 ACS (July 14, 2009)
  • K083029 — MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (December 5, 2008)
  • K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (November 26, 2007)
  • K073124 — COLLIMARE COLLIMATOR FAMILY (November 16, 2007)
  • K050092 — R605 FACS COLLIMETER (January 31, 2005)
  • K031597 — DUNLEE FORMAT COLLIMATOR FAMILY (July 21, 2003)
  • K990423 — PHILIPS NICOL COLLIMATOR FAMILY (March 15, 1999)
  • K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER (December 30, 1998)

FDA data resources