Cleared Traditional

K163328 - Planmed Clarity

K163328 is an FDA 510(k) clearance for Planmed Clarity, manufactured by Planmed OY. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K163328 · Planmed OY · Radiology device
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Dec 2017
Decision
395d
Days
Class 2
Risk

K163328 is an FDA 510(k) clearance for the Planmed Clarity. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on December 28, 2017 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Planmed OY devices

FDA 510(k) Submission Details - K163328

510(k) Number K163328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2016
Decision Date December 28, 2017
Days to Decision 395 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
288d slower than avg
Panel avg: 107d · This submission: 395d
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 K163328.
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K172404 · Ge Healthcare · Oct 2017
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K173132 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2017
Adani MammoScan
K172027 · Adani · Oct 2017