Cleared Traditional

K010116 - PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

K010116 is an FDA 510(k) clearance for PLANMED SOPHIE, 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 58-day FDA review.

K010116 · Planmed OY · Radiology device
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Mar 2001
Decision
58d
Days
Class 2
Risk

K010116 is an FDA 510(k) clearance for the PLANMED SOPHIE, PLANMED SOPHIE CLASSIC. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Planmed OY (Addison, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Planmed OY devices

FDA 510(k) Submission Details - K010116

510(k) Number K010116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date March 15, 2001
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 K010116.
SENOGRAPHIC STEREO
K040125 · Ge Medical Systems, Inc. · Apr 2004
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · Planmed OY · Feb 2003
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · Planmed OY · Jan 2002
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
DELTA 32 AND DELTA 32 TACT
K002472 · Instrumentarium Imaging, Inc. · Nov 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · Instrumentarium Imaging, Inc. · Jun 2000