Cleared Traditional

K863710 - ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

K863710 is an FDA 510(k) clearance for ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT, manufactured by Ausonics Pty , Ltd.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K863710 · Ausonics Pty , Ltd. · Radiology device
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Oct 1986
Decision
21d
Days
Class 2
Risk

K863710 is an FDA 510(k) clearance for the ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Ausonics Pty , Ltd. (Suffield, US). The FDA issued a Cleared decision on October 14, 1986 after a review of 21 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 Ausonics Pty , Ltd. devices

FDA 510(k) Submission Details - K863710

510(k) Number K863710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date October 14, 1986
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 48
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K863710.
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · Fischer Imaging Corp. · May 1988
ALPHA II DIAGNOSTIC X-RAY
K864958 · Ausonics Pty , Ltd. · Jan 1987
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · Fischer Imaging Corp. · Dec 1986
ISO-MAMMO
K860129 · Philips Medical Systems (Cleveland), Inc. · Mar 1986
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173 · Ausonics Pty , Ltd. · Apr 1985