Mobile Athena HF

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922454 ↗

FDA Product Code

IZH

Device Class

Class II

Regulation

21 CFR Part 892.1710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radiographic Floor Mounted Tubestand Fm 60

  Class I

  FDA 510(k) K893652 Active Cleared 23 Jun 1989

• Rms 180

  Class II

  FDA 510(k) K893673 Active Cleared 20 Jul 1989

• Elite R 90/15

  Class II

  FDA 510(k) K912741 Active Cleared 4 Oct 1991

• Fvp-1000 Family and Fvp-1000D Family

  Class II

  FDA 510(k) K905694 Active Cleared 27 Nov 1991

• Mammopath

  Class II

  FDA 510(k) K021113 Active Cleared 13 Jun 2002

• Imager

  Class II

  FDA 510(k) K883831 Active Cleared 21 Nov 1988

See all devices from Fischer Imaging Corp. →

• What is the Mobile Athena HF used for?

  The Mobile Athena HF is designed for X-ray imaging of the breast, intended for mammography screening in radiology settings, and can be transported to different locations for use.

• Is the Mobile Athena HF a single-use or reusable device?

  The Mobile Athena HF is a reusable system, as indicated by its classification and intended use requiring appropriate storage and handling per manufacturer instructions for repeated use.

• How is the Mobile Athena HF supplied and what are its regulatory details?

  The Mobile Athena HF is supplied as a complete mobile mammography system, FDA 510(k) cleared under K922454 on September 11, 1992, classified as Class II under product code IZH for System, X-ray, Mammographic.