510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K093466Substantially Equivalent

Hi Vision Preirus Doagnostic Ultrasound Scanner Model Hi Vision Preirus

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

K093466 is the FDA 510(k) clearance record for HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show one recall naming K093466.

Clearance record

Decision date
Received
(223 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
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 IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260