510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K991231Substantially Equivalent

Hitachi Versiflex

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

K991231 is the FDA 510(k) clearance record for HITACHI VERSIFLEX, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code IZI (System, X-Ray, Angiographic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K991231.

Clearance record

Decision date
Received
(42 days to decision)
Product code
IZI System, X-Ray, Angiographic
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code IZI

Trailing 12 months
2 clearances under product code IZI in the twelve months to November 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260