510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921112Substantially Equivalent

Fuji Computed Radiography Od-F623 Optical-Disk

FUJIFILM Healthcare Americas Corporation, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921112 is the FDA 510(k) clearance record for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK, a class II device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K921112.

Clearance record

Decision date
Received
(414 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Fujifilm Medical System U.S.A., Inc. 333 Ludlow St., Stamford CT
510(k) summary
Summary
Third party review
No

Clearances, product code KPR

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