Cleared Traditional

K193334 - Pristina Serena Bright

K193334 is an FDA 510(k) clearance for Pristina Serena Bright, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K193334 · Ge Healthcare · Radiology device
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May 2020
Decision
165d
Days
Class 2
Risk

K193334 is an FDA 510(k) clearance for the Pristina Serena Bright. 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 May 15, 2020 after a review of 165 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

FDA 510(k) Submission Details - K193334

510(k) Number K193334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date May 15, 2020
Days to Decision 165 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
58d slower than avg
Panel avg: 107d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K193334.
Planmed Clarity 2D and Clarity S
K192317 · Planmed OY · Oct 2020
Giotto Class (Models - 3000X-YY and 4000X-YY)
K200424 · Ims Giotto S.P.A. · Jun 2020
MAMMOMAT Revelation
K193166 · Siemens Medical Solutions USA, Inc. · Jun 2020
Sample Imaging for Senographe Pristina
K190809 · Ge Healthcare · Jul 2019
Pristina Serena 3D
K182951 · Ge Healthcare · Jan 2019
Pristina Serena
K173576 · Ge Healthcare · May 2018