Cleared Traditional

K861692 - FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM

K861692 is an FDA 510(k) clearance for FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM, manufactured by Fischer Imaging Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 227-day FDA review.

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

FDA 510(k) Submission Details - K861692

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
Combination Product No
PCCP Authorized No
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.

IZH Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K861692.
SHIMADZU MAMMOGRAPHIC STAND MR-30
K875377 · Shimadzu Precision Instruments, Inc. · Feb 1988
MAMEX DC S SL10/MG14
K874040 · Orion Corp. · Nov 1987
ALPHA II DIAGNOSTIC X-RAY
K864958 · Ausonics Pty , Ltd. · Jan 1987
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · Ausonics Pty , Ltd. · Oct 1986
TEC 2720 MAMEX DC MAG
K854203 · Tecnomed, Inc. · Mar 1986
ISO-MAMMO
K860129 · Philips Medical Systems (Cleveland), Inc. · Mar 1986