Cleared Traditional

K900689 - MODIFIED ADAC NUCLEAR MEDICINE GAMMA CA...

K900689 is the FDA 510(k) clearance for MODIFIED ADAC NUCLEAR MEDICINE GAMMA CA... by Adac Laboratories. It is a Class 1 Radiology device (product code IYX) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K900689 · Adac Laboratories · Radiology device
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Apr 1990
Decision
65d
Days
Class 1
Risk

K900689 is an FDA 510(k) clearance for the MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on April 19, 1990 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Adac Laboratories devices

Submission Details

510(k) Number K900689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date April 19, 1990
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 64
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K900689.
ES/ULTRA DISPLAY AND PROCESSING STATION
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