Cleared Traditional

K032779 - MODIFICATION TO: NUCAMMA RX

K032779 is an FDA 510(k) clearance for MODIFICATION TO: NUCAMMA RX, 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 100-day FDA review.

K032779 · Is2 Research, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
100d
Days
Class 2
Risk

K032779 is an FDA 510(k) clearance for the MODIFICATION TO: NUCAMMA RX. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Is2 Research, Inc. (Ottawa, Ontario, CA). The FDA issued a Cleared decision on December 17, 2003 after a review of 100 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 Is2 Research, Inc. devices

FDA 510(k) Submission Details - K032779

510(k) Number K032779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date December 17, 2003
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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 K032779.
AUTOQUANT PLUS
K040326 · Adac Laboratories · Feb 2004
MYOLIGHT
K033874 · Ge Medical Systems F.I. Haifa · Dec 2003
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003
VANTAGE PRO ATTENUATION CORRECTION DEVICE
K033735 · Adac Laboratories · Dec 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · Cti Pet Systems, Inc. · Nov 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · Adac Laboratories · Oct 2003