Cleared Traditional

K885020 - CYTOGUIDE

K885020 is the FDA 510(k) clearance for CYTOGUIDE 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 142-day FDA review.

K885020 · Philips Medical Systems North America, Inc. · Radiology device
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Apr 1989
Decision
142d
Days
Class 2
Risk

K885020 is an FDA 510(k) clearance for the CYTOGUIDE. 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 April 26, 1989 after a review of 142 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 Philips Medical Systems North America, Inc. devices

Submission Details

510(k) Number K885020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date April 26, 1989
Days to Decision 142 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
35d slower than avg
Panel avg: 107d · This submission: 142d
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 K885020.
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
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · Elscint, Inc. · Jan 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677 · Elscint, Inc. · Jan 1989
BREAST LESION LOCALIZATION NEEDLE
K881697 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988