510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K162221Substantially Equivalent

ACUSON SC2000 Diagnostic Ultrasound System

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

K162221 is the FDA 510(k) clearance record for ACUSON SC2000 Diagnostic Ultrasound System, a class II device, cleared for Siemens Medical Solutions Inc. Ultrasound Group on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list one 510(k) clearance for Siemens Medical Solutions Inc. Ultrasound Group. As of , FDA records show one recall naming K162221.

Clearance record

Decision date
Received
(29 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 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
55 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 20263