ICON— 510(k) K903315

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K903315 for ICON, Substantially Equivalent on 1991-01-09. Applicant: Siemens Gammasonics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code JWM
Device class: Class 2
Regulation: 21 CFR 892.1310
Advisory panel: Radiology
Date received: 1990-07-24
Decision date: 1991-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWM

K914350 — ICON COMPUTER SYSTEM1991-11-22
K904599 — D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM1991-04-23
K901545 — GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM1990-06-26
K874473 — ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM1988-07-18
K873075 — ADAC MODEL ARC-5000, GAMMA CAMERA1987-10-30

More clearances from Siemens Gammasonics, Inc.

K934766 — CARBON FIBER PALLET1994-02-18
K933664 — POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)1993-12-15
K933256 — FAN BEAM COLLIMATOR1993-10-29
K920319 — SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI1992-10-20
K923582 — SIENET CAMERA SERVER1992-10-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.