Cleared Traditional

K945619 - ATHENA HFX

K945619 is the FDA 510(k) clearance for ATHENA HFX by Fischer Imaging Corp.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K945619 · Fischer Imaging Corp. · Radiology device
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Mar 1995
Decision
128d
Days
Class 2
Risk

K945619 is an FDA 510(k) clearance for the ATHENA HFX. 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 March 23, 1995 after a review of 128 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 K945619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1994
Decision Date March 23, 1995
Days to Decision 128 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
21d slower than avg
Panel avg: 107d · This submission: 128d
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 K945619.
REAL TIME STEREOTIX
K941191 · GE Medical Systems · May 1995
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353 · Elscint, Inc. · Mar 1995
PREFERENCE MAMMOGRAPHY SYSTEM
K945743 · Philips Medical Systems (Cleveland), Inc. · Mar 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc. · Aug 1994