Cleared Traditional

K952564 - INSPECT/PROSPECT

K952564 is the FDA 510(k) clearance for INSPECT/PROSPECT by Adac Laboratories. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K952564 · Adac Laboratories · Radiology device
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Nov 1995
Decision
173d
Days
Class 2
Risk

K952564 is an FDA 510(k) clearance for the INSPECT/PROSPECT. 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 November 22, 1995 after a review of 173 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.

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Submission Details

510(k) Number K952564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date November 22, 1995
Days to Decision 173 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 107d · This submission: 173d
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 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K952564.
SPECTRADIGITAL SERIES V250DSP
K954129 · Hitachi Medical Corp. of America · Dec 1995
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
K954143 · Hitachi Medical Corp. of America · Dec 1995
VERTEX EPIC MCD
K952684 · Adac Laboratories · Nov 1995
VARICAM
K953801 · Elscint, Inc. · Nov 1995
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
K952674 · Elscint, Inc. · Sep 1995
IP500 NUCLEAR GAMMA CAMERA SYSTEM
K952109 · Siemens Medical Solutions USA, Inc. · Aug 1995