Cleared Traditional

K962105 - PLANNED SOPHIED CLASSIC

K962105 is the FDA 510(k) clearance for PLANNED SOPHIED CLASSIC by Planmed OY. It is a Class 2 Radiology device (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

Submission Details

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
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.

Device Classification

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 44
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K962105.
MAMMOTEST ADAPTER DRIVER
K973400 · Fischer Imaging Corp. · Nov 1997
GLORY
K970680 · Elscint, Inc. · Jun 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · Elscint, Inc. · Apr 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996
REAL TIME STEREOTIX
K941191 · GE Medical Systems · May 1995