510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931002Substantially Equivalent

Fuji Computed Radiograp Hi-C654 Dms Crt Image Cons

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

K931002 is the FDA 510(k) clearance record for FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS, a class II device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code IXK (System, Imaging, X-Ray, Electrostatic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K931002.

Clearance record

Decision date
Received
(102 days to decision)
Product code
IXK System, Imaging, X-Ray, Electrostatic
Regulation
21 CFR 892.1630
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 IXK

Trailing 12 months

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

FDA records show no clearances under product code IXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXK, 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