Cleared Traditional

K013667 - BCC GAMMA CAMERA

K013667 is an FDA 510(k) clearance for BCC GAMMA CAMERA, manufactured by Is2 Research, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K013667 · Is2 Research, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
83d
Days
Class 2
Risk

K013667 is an FDA 510(k) clearance for the BCC GAMMA CAMERA. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Is2 Research, Inc. (Nepean, Ontario, CA). The FDA issued a Cleared decision on January 28, 2002 after a review of 83 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 Is2 Research, Inc. devices

FDA 510(k) Submission Details - K013667

510(k) Number K013667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date January 28, 2002
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
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 347
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K013667.
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · Cti Pet Systems, Inc. · Aug 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · Ge Medical Systems, Inc. · Aug 2002
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · Adac Laboratories · Nov 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
K013504 · Cti Pet Systems, Inc. · Oct 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · GE Medical Systems · Sep 2001