Cleared Traditional

K973493 - PLANMED CYTOGUIDE

K973493 is the FDA 510(k) clearance for PLANMED CYTOGUIDE by Planmed OY. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K973493 · Planmed OY · Radiology device
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Nov 1997
Decision
56d
Days
Class 2
Risk

K973493 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 (Wood Dale, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Planmed OY devices

Submission Details

510(k) Number K973493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1997
Decision Date November 10, 1997
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 K973493.
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313 · Elscint, Inc. · Dec 1998
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