Cleared Traditional

K153402 - Discovery NM/CT 670 CZT

K153402 is an FDA 510(k) clearance for Discovery NM/CT 670 CZT, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K153402 · Ge Healthcare · Radiology device
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Jan 2016
Decision
58d
Days
Class 2
Risk

K153402 is an FDA 510(k) clearance for the Discovery NM/CT 670 CZT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on January 21, 2016 after a review of 58 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.

View all Ge Healthcare devices

FDA 510(k) Submission Details - K153402

510(k) Number K153402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date January 21, 2016
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 368
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K153402.
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