Cleared Traditional

K001026 - 3D-MSPECT

K001026 is an FDA 510(k) clearance for 3D-MSPECT, manufactured by The Reagents of the University of Michigan. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K001026 · The Reagents of the University of Michigan · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
82d
Days
Class 2
Risk

K001026 is an FDA 510(k) clearance for the 3D-MSPECT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by The Reagents of the University of Michigan (North Attleboro, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 82 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 The Reagents of the University of Michigan devices

FDA 510(k) Submission Details - K001026

510(k) Number K001026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date June 20, 2000
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 363
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K001026.
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