510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K110202Substantially Equivalent

Fujifilm Diagnostic Ultrasound System Fazone Cb

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

K110202 is the FDA 510(k) clearance record for FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB, a class II device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K110202.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
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
Yes

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260
November 20260