Cleared Traditional

K934373 - MOBILE SOPHIE MODIFICATION

K934373 is an FDA 510(k) clearance for MOBILE SOPHIE MODIFICATION, 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 211-day FDA review.

K934373 · Planmed OY · Radiology device
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Apr 1994
Decision
211d
Days
Class 2
Risk

K934373 is an FDA 510(k) clearance for the MOBILE SOPHIE MODIFICATION. 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 April 7, 1994 after a review of 211 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 - K934373

510(k) Number K934373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1993
Decision Date April 07, 1994
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
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 K934373.
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc. · Aug 1994
BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH
K940701 · Bennett X-Ray Corp. · Apr 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · Elscint, Inc. · Aug 1993
CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR
K925725 · Bennett X-Ray Corp. · Feb 1993