Cleared Traditional

K896609 - CYTOGUIDE FOR USE W/THE PHILMEDISYST MA...

K896609 is the FDA 510(k) clearance for CYTOGUIDE FOR USE W/THE PHILMEDISYST MA... by Philips Medical Systems North America, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K896609 · Philips Medical Systems North America, Inc. · Radiology device
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Jan 1990
Decision
175d
Days
Class 2
Risk

K896609 is an FDA 510(k) clearance for the CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on January 31, 1990 after a review of 175 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 Philips Medical Systems North America, Inc. devices

Submission Details

510(k) Number K896609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1989
Decision Date January 31, 1990
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 107d · This submission: 175d
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 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K896609.
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
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · Siemens Medical Solutions USA, Inc. · May 1989
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989
CYTOGUIDE
K885020 · Philips Medical Systems North America, Inc. · Apr 1989