Cleared Traditional

Mammomat Revelation (K173408) - FDA 510(k) Clearance

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

K173408 · Siemens Medi Cal Solutions, Inc. · Radiology device
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Mar 2018
Decision
140d
Days
Class 2
Risk

K173408 is an FDA 510(k) clearance for the Mammomat Revelation. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Malvern, US). The FDA issued a Cleared decision on March 21, 2018 after a review of 140 days - within the typical 510(k) review window.

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 Siemens Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K173408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2017
Decision Date March 21, 2018
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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 53
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