510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900562Substantially Equivalent

Trans X 100 Chest Film Changer

Acoma Medical Imaging, Inc., Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900562 is the FDA 510(k) clearance record for TRANS X 100 CHEST FILM CHANGER, a class II device, cleared for Acoma Medical Imaging, Inc. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 13 510(k) clearances for Acoma Medical Imaging, Inc., from to . As of , FDA records show no recalls naming K900562.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Acoma Medical Imaging, Inc. 150 Chaddick Dr., Wheeling IL
Third party review
No

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260