Cleared Traditional

K021945 - PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)

K021945 is an FDA 510(k) clearance for PLANMED SOPHIE & SOPHIE CLASSIC (WITH D..., manufactured by Planmed OY. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K021945 · Planmed OY · Radiology device
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Feb 2003
Decision
253d
Days
Class 2
Risk

K021945 is an FDA 510(k) clearance for the PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE). Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Planmed OY (Roselle, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 253 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 - K021945

510(k) Number K021945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2002
Decision Date February 21, 2003
Days to Decision 253 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 107d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 104
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K021945.
MAMMOTEST
K042095 · Fischer Imaging Corp. · Oct 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 2004
SENOGRAPHIC STEREO
K040125 · Ge Medical Systems, Inc. · Apr 2004
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · Planmed OY · Jan 2002
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · Planmed OY · Mar 2001
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001