Cleared Traditional

K163328 - Planmed Clarity (FDA 510(k) Clearance)

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

K163328 · Planmed OY · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 K163328.
Senographe Pristina
K260087 · GE Medical Systems SCS · Mar 2026
HESTIA
K243420 · Genoray Co., Ltd. · Jul 2025
2430TCA with Xmaru W
K243849 · Rayence Co., Ltd. · Mar 2025
VIVIX-M
K241113 · Vieworks Co., Ltd. · Jan 2025
MAMMOMAT B.brilliant
K233539 · Siemens Medical Solutions USA, Inc. · Mar 2024
RMF-2000
K220073 · DRTECH Corporation · Jan 2023