510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K073650Substantially Equivalent

Fujifilm Unity Speedsuite, Model Cr-Ir 371

FUJIFILM Healthcare Americas Corporation, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073650 is the FDA 510(k) clearance record for FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371, a class II device, cleared for Fujifilm Medical Systems 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 K073650.

Clearance record

Decision date
Received
(42 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 Systems U.S.A, Inc. P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
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