Cleared Traditional

K962105 - PLANNED SOPHIED CLASSIC

K962105 is an FDA 510(k) clearance for PLANNED SOPHIED CLASSIC, 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 250-day FDA review.

K962105 · Planmed OY · Radiology device
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Feb 1997
Decision
250d
Days
Class 2
Risk

K962105 is an FDA 510(k) clearance for the PLANNED SOPHIED 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 February 5, 1997 after a review of 250 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 - K962105

510(k) Number K962105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date February 05, 1997
Days to Decision 250 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
143d slower than avg
Panel avg: 107d · This submission: 250d
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 K962105.
GLORY
K970680 · Elscint, Inc. · Jun 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · Medical Marketing Intl., Inc. · Mar 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · Bennett X-Ray Corp. · Jan 1997
THE ROBOGUIDE
K961849 · Shai Syg Motion and Innovations, Ltd. · Aug 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · Elscint, Inc. · Apr 1996