Cleared Traditional

VANTAGE, FOR ADAC GAMMA CAMERAS (K943596) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943596 · Adac Laboratories · Radiology device
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Apr 1995
Decision
275d
Days
Class 2
Risk

K943596 is an FDA 510(k) clearance for the VANTAGE, FOR ADAC GAMMA CAMERAS. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 275 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Adac Laboratories devices

Submission Details

510(k) Number K943596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1994
Decision Date April 26, 1995
Days to Decision 275 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 107d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 169
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K943596.
SPECTEF PROTOCOL
K954874 · GE Medical Systems · Feb 1996
IP500 NUCLEAR GAMMA CAMERA SYSTEM
K952109 · Siemens Medical Solutions USA, Inc. · Aug 1995
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS
K951144 · GE Medical Systems · Jul 1995
ATTENUATION CORRECTION
K945652 · GE Medical Systems · Mar 1995
NON-UNIFORM ATTENUATION CORRECTION SYSTEM
K942145 · Siemens Medical Solutions USA, Inc. · Feb 1995
ADVANCE ANALYSIS SOFTWARE
K941223 · General Electric Co. · Nov 1994