Cleared Traditional

K003358 - QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)

K003358 is an FDA 510(k) clearance for QPS (QUANTITATIVE PERFUSION SPECT), manufactured by Smv America. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K003358 · Smv America · Radiology device
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Jan 2001
Decision
85d
Days
Class 2
Risk

K003358 is an FDA 510(k) clearance for the QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Smv America (Twinsburg, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smv America devices

FDA 510(k) Submission Details - K003358

510(k) Number K003358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2000
Decision Date January 19, 2001
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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 356
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K003358.
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co. · Sep 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · Digirad Corp. · Jun 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001
GE ADVANCE NXI PET SYSTEM
K003849 · Ge Medical Systems, Inc. · Dec 2000
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
K003264 · Ge Medical Systems F.I. Haifa · Dec 2000
ECAT PET SCANNER
K003241 · Cti Pet Systems, Inc. · Dec 2000