Cleared Traditional

K953801 - VARICAM

K953801 is the FDA 510(k) clearance for VARICAM by Elscint, Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K953801 · Elscint, Inc. · Radiology device
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Nov 1995
Decision
103d
Days
Class 2
Risk

K953801 is an FDA 510(k) clearance for the VARICAM. 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 November 22, 1995 after a review of 103 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 K953801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1995
Decision Date November 22, 1995
Days to Decision 103 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
4d faster than avg
Panel avg: 107d · This submission: 103d
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 K953801.
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K954143 · Hitachi Medical Corp. of America · Dec 1995
VERTEX EPIC MCD
K952684 · Adac Laboratories · Nov 1995
INSPECT/PROSPECT
K952564 · Adac Laboratories · 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
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS
K951144 · GE Medical Systems · Jul 1995