Cleared Traditional

K123599 - INGENUITY DIGITAL PET/CT

K123599 is an FDA 510(k) clearance for INGENUITY DIGITAL PET/CT, manufactured by Philips Healthcare (Cleveland). The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K123599 · Philips Healthcare (Cleveland) · Radiology device
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Jul 2013
Decision
233d
Days
Class 2
Risk

K123599 is an FDA 510(k) clearance for the INGENUITY DIGITAL PET/CT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Philips Healthcare (Cleveland) (Cleveland, US). The FDA issued a Cleared decision on July 12, 2013 after a review of 233 days - an extended review 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: 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 Philips Healthcare (Cleveland) devices

FDA 510(k) Submission Details - K123599

510(k) Number K123599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date July 12, 2013
Days to Decision 233 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
126d slower than avg
Panel avg: 107d · This submission: 233d
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 406
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K123599.
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