510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080945Substantially Equivalent

Fcr Go Portable Digital X-Ray System

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

K080945 is the FDA 510(k) clearance record for FCR GO PORTABLE DIGITAL X-RAY SYSTEM, a class II device, cleared for Fujifilm Medical Systems U.S.A, Inc. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K080945.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Fujifilm Medical Systems U.S.A, Inc. 419 W. Ave., Stamford CT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IZL

Trailing 12 months
7 clearances under product code IZL in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20261
November 20260