Cleared Traditional

K903469 - GAMMA 600 NUCLEAR MEDICINE COMPUTER

K903469 is an FDA 510(k) clearance for GAMMA 600 NUCLEAR MEDICINE COMPUTER, manufactured by Strichman Medical Equipment, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 187-day FDA review.

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

FDA 510(k) Submission Details - K903469

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.

IYX Device Classification - Class 1, General Controls

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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 89
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K903469.
NEUROCAM
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K904050 · Philips Medical Systems (Cleveland), Inc. · Dec 1990
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
K900689 · Adac Laboratories · Apr 1990