Cleared Special

K112474 - CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE

K112474 is an FDA 510(k) clearance for CSMC CARDIAC SUITE- NUCLEAR MEDICINE SO..., manufactured by Cedars-Sinai Medical Center. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 28-day FDA review.

K112474 · Cedars-Sinai Medical Center · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
28d
Days
Class 2
Risk

K112474 is an FDA 510(k) clearance for the CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cedars-Sinai Medical Center (Los Angeles, US). The FDA issued a Cleared decision on September 23, 2011 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112474

510(k) Number K112474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2011
Decision Date September 23, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 472
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K112474.
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K112474 · CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
Download PDF FDA Summary Cedars-Sinai Medical …