Cleared Traditional

PLANMED CYTOGUIDE (K923471) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923471 · Planmed OY · Radiology device
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Nov 1992
Decision
133d
Days
Class 2
Risk

K923471 is an FDA 510(k) clearance for the PLANMED CYTOGUIDE. 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 24, 1992 after a review of 133 days - within the typical 510(k) review window.

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 K923471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1992
Decision Date November 24, 1992
Days to Decision 133 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
26d slower than avg
Panel avg: 107d · This submission: 133d
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 175
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K923471.
SMART FINDER
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OPDIMA
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K964069 · Siemens Medical Solutions USA, Inc. · May 1997
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994