Cleared Traditional

K163328 - Planmed Clarity

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

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 39
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K163328.
Pristina Serena 3D
K182951 · Ge Healthcare · Jan 2019
Pristina Serena
K173576 · Ge Healthcare · May 2018
Mammomat Revelation
K173408 · Siemens Medi Cal Solutions, Inc. · Mar 2018
SenoBright HD
K172404 · Ge Healthcare · Oct 2017
ASPIRE Cristalle
K173132 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2017
Senographe Pristina
K163302 · Ge Healthcare · Sep 2017