Cleared Traditional

K945619 - ATHENA HFX (FDA 510(k) Clearance)

K945619 · Fischer Imaging Corp. · Radiology device

Mar 1995

Decision

128d

Days

Class 2

Risk

K945619 is an FDA 510(k) clearance for the ATHENA HFX. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on March 23, 1995, 128 days after receiving the submission on November 15, 1994.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.

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