510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K121499Substantially Equivalent

Fujifilm Tomosynthesis Option for Fdr Acselerate Stationary 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)

K121499 is the FDA 510(k) clearance record for FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM, a class II device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K121499.

Clearance record

Decision date
Received
(183 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
Device class
Class II
Review panel
Radiology
Applicant
Fujifilm Medical System U.S.A., Inc. 419 W. Ave., Stamford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZF

Trailing 12 months
1 clearance under product code IZF in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260