510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K903315Substantially Equivalent

Icon

Siemens Gammasonics, Inc., Hoffman Estates IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903315 is the FDA 510(k) clearance record for ICON, a class II device, cleared for Siemens Gammasonics, Inc. on under FDA product code JWM (System, Tomographic, Nuclear). FDA records list 53 510(k) clearances for Siemens Gammasonics, Inc., from to . As of , FDA records show one recall naming K903315.

Clearance record

Decision date
Received
(169 days to decision)
Product code
JWM System, Tomographic, Nuclear
Regulation
21 CFR 892.1310
Device class
Class II
Review panel
Radiology
Applicant
Siemens Gammasonics, Inc. 2501 N. Barrington Rd., Hoffman Estates IL
Third party review
No

Clearances, product code JWM

Trailing 12 months

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

FDA records show no clearances under product code JWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JWM, 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