Cleared Traditional

K163302 - Senographe Pristina (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163302 · Ge Healthcare · Radiology device
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Sep 2017
Decision
283d
Days
Class 2
Risk

K163302 is an FDA 510(k) clearance for the Senographe Pristina. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Ge Healthcare (Buc, FR). The FDA issued a Cleared decision on September 1, 2017 after a review of 283 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - 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 Ge Healthcare devices

Submission Details

510(k) Number K163302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date September 01, 2017
Days to Decision 283 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 107d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
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 - MUE Full Field Digital, System, X-ray, Mammographic

All 52
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K163302.
Senographe Pristina
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