510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K110673Substantially Equivalent

Hi Vision Ascendus Diagnostic Ultrasound Scanner

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

K110673 is the FDA 510(k) clearance record for HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K110673.

Clearance record

Decision date
Received
(202 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park, Twinsburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYN

Trailing 12 months
50 clearances under product code IYN in the twelve months to November 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20264
November 20260