Cleared Traditional

K904953 - PLANMED SOPHIE

K904953 is the FDA 510(k) clearance for PLANMED SOPHIE by Planmeca USA, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K904953 · Planmeca USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
164d
Days
Class 2
Risk

K904953 is an FDA 510(k) clearance for the PLANMED SOPHIE. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on April 18, 1991 after a review of 164 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 Planmeca USA, Inc. devices

Submission Details

510(k) Number K904953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1990
Decision Date April 18, 1991
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
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 K904953.
PHILIPS MAMMODIAGNOST BC
K913845 · Philips Medical Systems, Inc. · Dec 1991
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328 · Siemens Medical Solutions USA, Inc. · Dec 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
K912974 · Elscint, Inc. · Sep 1991
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989 · Fischer Imaging Corp. · Mar 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609 · Philips Medical Systems North America, Inc. · Jan 1990
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · Siemens Medical Solutions USA, Inc. · May 1989