Cleared Traditional

K172027 - Adani MammoScan

K172027 is an FDA 510(k) clearance for Adani MammoScan, manufactured by Adani. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K172027 · Adani · Radiology device
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Oct 2017
Decision
107d
Days
Class 2
Risk

K172027 is an FDA 510(k) clearance for the Adani MammoScan. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Adani (Minsk, BY). The FDA issued a Cleared decision on October 20, 2017 after a review of 107 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 Adani devices

FDA 510(k) Submission Details - K172027

510(k) Number K172027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date October 20, 2017
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
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 Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K172027.
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