Cleared Traditional

FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM (K861692) - FDA 510(k) Clearance

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

K861692 · Fischer Imaging Corp. · Radiology device
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Dec 1986
Decision
227d
Days
Class 2
Risk

K861692 is an FDA 510(k) clearance for the FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Elk Grove Village, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 227 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 Fischer Imaging Corp. devices

Submission Details

510(k) Number K861692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1986
Decision Date December 15, 1986
Days to Decision 227 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 107d · This submission: 227d
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 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K861692.
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989
BREAST LESION LOCALIZATION NEEDLE
K881697 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988
ISO-MAMMO
K860129 · Philips Medical Systems (Cleveland), Inc. · Mar 1986