Cleared Traditional

K973396 - QUEST PET IMAGING SYSTEM

K973396 is an FDA 510(k) clearance for QUEST PET IMAGING SYSTEM, manufactured by Ugm Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K973396 · Ugm Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
149d
Days
Class 2
Risk

K973396 is an FDA 510(k) clearance for the QUEST PET IMAGING SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ugm Medical Systems, Inc. (Philadelphia, US). The FDA issued a Cleared decision on January 21, 1998 after a review of 149 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 Ugm Medical Systems, Inc. devices

FDA 510(k) Submission Details - K973396

510(k) Number K973396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date January 21, 1998
Days to Decision 149 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
42d slower than avg
Panel avg: 107d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

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 355
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K973396.
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
K980715 · Adac Laboratories · May 1998
ECAT PET SCANNERS
K974256 · Cti Pet Systems, Inc. · Feb 1998
NUMASTATION
K974444 · Numa, Inc. · Feb 1998
IMAGE FUSION AND REVIEW SYSTEM
K973233 · Adac Laboratories · Nov 1997
MCD-AC
K971980 · Adac Laboratories · Oct 1997
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
K972686 · Smv America · Oct 1997