Cleared Traditional

K903469 - GAMMA 600 NUCLEAR MEDICINE COMPUTER (FDA 510(k) Clearance)

Class I Radiology device.

K903469 · Strichman Medical Equipment, Inc. · Radiology device
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Feb 1991
Decision
187d
Days
Class 1
Risk

K903469 is an FDA 510(k) clearance for the GAMMA 600 NUCLEAR MEDICINE COMPUTER. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Strichman Medical Equipment, Inc. (Medfield, US). The FDA issued a Cleared decision on February 4, 1991 after a review of 187 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Strichman Medical Equipment, Inc. devices

Submission Details

510(k) Number K903469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date February 04, 1991
Days to Decision 187 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 107d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.