Cleared Traditional

K033199 - COMPACT DIGITAL CARDIAC CAMERA (CDCC)

K033199 is an FDA 510(k) clearance for COMPACT DIGITAL CARDIAC CAMERA (CDCC), manufactured by Is2 Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K033199 · Is2 Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
41d
Days
Class 2
Risk

K033199 is an FDA 510(k) clearance for the COMPACT DIGITAL CARDIAC CAMERA (CDCC). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Is2 Medical Systems, Inc. (Ottawa, Ontario, CA). The FDA issued a Cleared decision on November 12, 2003 after a review of 41 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.

FDA 510(k) Submission Details - K033199

510(k) Number K033199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2003
Decision Date November 12, 2003
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
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 470
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K033199.
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K033199 · COMPACT DIGITAL CARDIAC CAMERA (CDCC)
Download PDF FDA Summary Is2 Medical Systems, …