Cleared Traditional

K903315 - ICON

K903315 is an FDA 510(k) clearance for ICON, manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code JWM cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K903315 · Siemens Gammasonics, Inc. · Radiology device
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Jan 1991
Decision
169d
Days
Class 2
Risk

K903315 is an FDA 510(k) clearance for the ICON. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on January 9, 1991 after a review of 169 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1310 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Gammasonics, Inc. devices

FDA 510(k) Submission Details - K903315

510(k) Number K903315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date January 09, 1991
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWM Device Classification - Class 2, Special Controls

Product Code JWM System, Tomographic, Nuclear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JWM System, Tomographic, Nuclear

All 14
Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K903315.
ICON COMPUTER SYSTEM
K914350 · Siemens Gammasonics, Inc. · Nov 1991
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
K901545 · Toshiba America Medical Systems, In.C · Jun 1990
ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM
K874473 · Adac Laboratories · Jul 1988
ADAC MODEL ARC-5000, GAMMA CAMERA
K873075 · Adac Laboratories · Oct 1987
DIGITAL GAMMA CAMERA GCA 601 E
K851685 · Toshiba Medical Systems · Jun 1985
STARCAM DATA ACQUISITION & PROCESSING SYS H3300C
K850885 · General Electric Co. · Jun 1985