Cleared Special

K141652 - CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE

K141652 is an FDA 510(k) clearance for CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDI..., 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 32-day FDA review.

K141652 · Cedars-Sinai Medical Center · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
32d
Days
Class 2
Risk

K141652 is an FDA 510(k) clearance for the CEDARS-SINAI 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 July 22, 2014 after a review of 32 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 - K141652

510(k) Number K141652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2014
Decision Date July 22, 2014
Days to Decision 32 days
Submission Type Special
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
75d faster than avg
Panel avg: 107d · This submission: 32d
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.

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All 440
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