510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912364Substantially Equivalent

Electronic Ultrasound Scanner Eub-315, Modified

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

K912364 is the FDA 510(k) clearance record for ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED, a class II device, cleared for Hitachi Medical Corp. of America on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 32 510(k) clearances for Hitachi Medical Corp. of America, from to . As of , FDA records show no recalls naming K912364.

Clearance record

Decision date
Received
(455 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Corp. of America 50 Prospect Ave., Tarrytown NY
510(k) summary
Statement
Third party review
No

Clearances, product code ITX

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