Cleared Traditional

K922454 - MOBILE ATHENA HF

K922454 is the FDA 510(k) clearance for MOBILE ATHENA HF by Fischer Imaging Corp.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K922454 · Fischer Imaging Corp. · Radiology device
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Sep 1992
Decision
108d
Days
Class 2
Risk

K922454 is an FDA 510(k) clearance for the MOBILE ATHENA HF. 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 September 11, 1992 after a review of 108 days - within the typical 510(k) review window.

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 K922454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1992
Decision Date September 11, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
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 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K922454.
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc. · Aug 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · Elscint, Inc. · Aug 1993
MAMMOSCAN
K923061 · Fischer Imaging Corp. · Sep 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992
SENOGRAPHE DMR/SMR/DM
K913418 · General Electric Co. · Jan 1992