Cleared Abbreviated

K983659 - PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

K983659 is an FDA 510(k) clearance for PLANMED SOPHIE & PLANNED SOPHIE CLASSIC, manufactured by Planmed OY. The device is a Class 2 Radiology device with product code IZH cleared through the Abbreviated 510(k) pathway after a 28-day FDA review.

K983659 · Planmed OY · Radiology device
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Nov 1998
Decision
28d
Days
Class 2
Risk

K983659 is an FDA 510(k) clearance for the PLANMED SOPHIE & PLANNED SOPHIE CLASSIC. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on November 16, 1998 after a review of 28 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Planmed OY devices

FDA 510(k) Submission Details - K983659

510(k) Number K983659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date November 16, 1998
Days to Decision 28 days
Submission Type Abbreviated
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Standards-based clearance path.

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 K983659.
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
K984091 · Trex Medical Corp. · Feb 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092 · Trex Medical Corp. · Feb 1999
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313 · Elscint, Inc. · Dec 1998
NEEDLE GUIDE
K983621 · Remington Medical, Inc. · Nov 1998
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
K981641 · Instrumentarium Corp. · Jul 1998
BIOPSY M
K982049 · Sitco, Inc. · Jul 1998