Cleared Traditional

K121963 - PLANMED NUANCE DIGIGUIDE

K121963 is an FDA 510(k) clearance for PLANMED NUANCE DIGIGUIDE, 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 139-day FDA review.

K121963 · Planmed OY · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K121963

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
Combination Product No
PCCP Authorized No
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.

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 K121963.
MAMMOMAL INSPIRATION
K122286 · Siemens Medical Solutions USA, Inc. · Feb 2013
MICRODOSE SI
K123995 · Philips Digital Mammography Sweden AB · 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
PHILIPS MICRODOSE
K120255 · Philips Digital Mammography Sweden AB · Apr 2012