Cleared Traditional

K121963 - PLANMED NUANCE DIGIGUIDE

K121963 is the FDA 510(k) clearance for PLANMED NUANCE DIGIGUIDE by Planmed OY. It is a Class 2 Radiology device (product code MUE) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K121963 · Planmed OY · Radiology device
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Nov 2012
Decision
139d
Days
Class 2
Risk

K121963 is an FDA 510(k) clearance for the PLANMED NUANCE DIGIGUIDE. 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 November 21, 2012 after a review of 139 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 Planmed OY devices

Submission Details

510(k) Number K121963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date November 21, 2012
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
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 K121963.
MAMMOMAT INSPIRATION PRIME
K123520 · Siemens Medical Solutions USA, Inc. · Jun 2013
MAMMOMAL INSPIRATION
K122286 · Siemens Medical Solutions USA, Inc. · Feb 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · Hologic, Inc. · Jan 2013
ASPIRE HD PLUS, ASPIRE HD-S
K121674 · Fujifilm Medical System U.S.A., Inc. · Sep 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
K120246 · Carestream Health, Inc. · Aug 2012
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)
K111646 · Fujifilm Medical System U.S.A., Inc. · Dec 2011