510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163635Substantially Equivalent

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems

Siemens Medical Solutions USA, Inc. Ultrasound Group, Moutain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163635 is the FDA 510(k) clearance record for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems, a class II device, cleared for Siemens Medical Solutions USA, Inc. Ultrasound Group on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 3 510(k) clearances for Siemens Medical Solutions USA, Inc. Ultrasound Group, from to . As of , FDA records show one recall naming K163635.

Clearance record

Decision date
Received
(21 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. Ultrasound Group 685 E. Middlefield Rd., Moutain View CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYN

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