Cleared Traditional

K880531 - MAMMOGRAPHIC X-RAY SYSTEM ATHENA

K880531 is an FDA 510(k) clearance for MAMMOGRAPHIC X-RAY SYSTEM ATHENA, 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 83-day FDA review.

K880531 · Fischer Imaging Corp. · Radiology device
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May 1988
Decision
83d
Days
Class 2
Risk

K880531 is an FDA 510(k) clearance for the MAMMOGRAPHIC X-RAY SYSTEM ATHENA. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 83 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 Fischer Imaging Corp. devices

FDA 510(k) Submission Details - K880531

510(k) Number K880531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date May 02, 1988
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
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 K880531.
MAMEX DC MG11
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K881506 · Orion Corp. · Jun 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988
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