Cleared Traditional

K952674 - TRANSACT: ATTENUATION CORRECTION SYSTEM...

K952674 is the FDA 510(k) clearance for TRANSACT: ATTENUATION CORRECTION SYSTEM... by Elscint, Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K952674 · Elscint, Inc. · Radiology device
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Sep 1995
Decision
106d
Days
Class 2
Risk

K952674 is an FDA 510(k) clearance for the TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on September 26, 1995 after a review of 106 days - within the typical 510(k) review window.

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 Elscint, Inc. devices

Submission Details

510(k) Number K952674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date September 26, 1995
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 K952674.
VERTEX EPIC MCD
K952684 · Adac Laboratories · Nov 1995
INSPECT/PROSPECT
K952564 · Adac Laboratories · Nov 1995
VARICAM
K953801 · Elscint, Inc. · Nov 1995
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
VANTAGE, FOR ADAC GAMMA CAMERAS
K943596 · Adac Laboratories · Apr 1995