Cleared Traditional

K904599 - D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM

K904599 is an FDA 510(k) clearance for D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMP..., manufactured by Digital Design, Inc.. The device is a Class 2 Radiology device with product code JWM cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K904599 · Digital Design, Inc. · Radiology device
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Apr 1991
Decision
195d
Days
Class 2
Risk

K904599 is an FDA 510(k) clearance for the D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Digital Design, Inc. (Norcross, US). The FDA issued a Cleared decision on April 23, 1991 after a review of 195 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 Digital Design, Inc. devices

FDA 510(k) Submission Details - K904599

510(k) Number K904599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date April 23, 1991
Days to Decision 195 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 107d · This submission: 195d
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 15
Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K904599.
ICON COMPUTER SYSTEM
K914350 · Siemens Gammasonics, Inc. · Nov 1991
ICON
K903315 · Siemens Gammasonics, Inc. · Jan 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