510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093572Substantially Equivalent

R650 Qdasm Collimator

Omega Medical Imaging, LLC, Sanford FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093572 is the FDA 510(k) clearance record for R650 QDASM COLLIMATOR, a class II device, cleared for Omega Medical Imaging, Inc. on under FDA product code IZW (Collimator, Automatic, Radiographic). FDA records list 15 510(k) clearances for Omega Medical Imaging, Inc., from to . As of , FDA records show no recalls naming K093572.

Clearance record

Decision date
Received
(77 days to decision)
Product code
IZW Collimator, Automatic, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Omega Medical Imaging, Inc. 675 Hickman Cir., Sanford FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZW

Trailing 12 months

FDA records hold no clearances under product code IZW in the trailing twelve months.

FDA records show no clearances under product code IZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260