510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945400Substantially Equivalent

Hitachi Dynamic 3D Imaging System,sf-Va100

Hitachi Medical Corp. of America, Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945400 is the FDA 510(k) clearance record for HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100, a class II device, cleared for Hitachi Medical Corp. of America on under FDA product code IZI (System, X-Ray, Angiographic). FDA records list 32 510(k) clearances for Hitachi Medical Corp. of America, from to . As of , FDA records show no recalls naming K945400.

Clearance record

Decision date
Received
(382 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 Corp. of America 660 White Plains Rd., Tarrytown NY
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 October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260