Cleared Traditional

NUQUEST NUCLEAR MEDICINE COMPUTER (K953255) - FDA 510(k) Clearance

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

K953255 · Sitco, Inc. · Radiology device
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Oct 1995
Decision
104d
Days
Class 2
Risk

K953255 is an FDA 510(k) clearance for the NUQUEST NUCLEAR MEDICINE COMPUTER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Sitco, Inc. (Mundelein, US). The FDA issued a Cleared decision on October 24, 1995 after a review of 104 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 Sitco, Inc. devices

Submission Details

510(k) Number K953255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date October 24, 1995
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
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 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K953255.
PRISM 3000XPV SYSTEM (210714)
K961577 · Philips Medical Systems (Cleveland), Inc. · Jul 1996
XENON OPTION TO PRISM 3000
K955484 · Philips Medical Systems (Cleveland), Inc. · Mar 1996
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