Cleared Traditional

K860129 - ISO-MAMMO

K860129 is an FDA 510(k) clearance for ISO-MAMMO, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K860129 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Mar 1986
Decision
51d
Days
Class 2
Risk

K860129 is an FDA 510(k) clearance for the ISO-MAMMO. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 51 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K860129

510(k) Number K860129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date March 06, 1986
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 105
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K860129.
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · Fischer Imaging Corp. · Dec 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · Ausonics Pty , Ltd. · Oct 1986
TEC 2720 MAMEX DC MAG
K854203 · Tecnomed, Inc. · Mar 1986
MINXRAY 500M MAMMOGRAPHIC SYSTEM
K854510 · Minxray, Inc. · Jan 1986
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173 · Ausonics Pty , Ltd. · Apr 1985