Cleared Traditional

K001681 - POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM

K001681 is an FDA 510(k) clearance for POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM, 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.

K001681 · Smv America · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
85d
Days
Class 2
Risk

K001681 is an FDA 510(k) clearance for the POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM. 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 August 25, 2000 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 - K001681

510(k) Number K001681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2000
Decision Date August 25, 2000
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 K001681.
ECAT ACCEL PET SCANNER
K002584 · Cti Pet Systems, Inc. · Nov 2000
ALLEGRO TB, ALLEGRO N
K003434 · Adac Laboratories · Nov 2000
ECAT PET SCANNER
K002715 · Cti Pet Systems, Inc. · Oct 2000
SKYLIGHT IMAGING SYSTEM
K000908 · Adac Laboratories · Apr 2000
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)
K994167 · Ge Medical Systems F.I. Haifa · Mar 2000
MEDX INTECAM INTERFACE
K993893 · Medx, Inc. · Feb 2000