510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910426Substantially Equivalent

Sdu 500 Diagnostic Ultrasound Instrument

Shimadzu Medical Systems, Gardena CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910426 is the FDA 510(k) clearance record for SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT, a class II device, cleared for Shimadzu Medical Systems on under FDA product code HEM (Imager, Ultrasonic Obstetric-Gynecologic). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K910426.

Clearance record

Decision date
Received
(127 days to decision)
Product code
HEM Imager, Ultrasonic Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Shimadzu Medical Systems 101 W. Walnut St., Gardena CA
Third party review
No

Clearances, product code HEM

Trailing 12 months

FDA records hold no clearances under product code HEM in the trailing twelve months.

FDA records show no clearances under product code HEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260