Mammographic X-Ray System Athena

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

510(k) Number

K880531 ↗

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 primary clinical use of the Mammographic X-Ray System Athena in a radiology setting?

  The Mammographic X-Ray System Athena is designed specifically for breast cancer screening and diagnosis. It uses X-ray technology to create detailed images of breast tissue, helping radiologists detect abnormalities such as tumors or calcifications. This aids in early detection and evaluation of breast conditions.

• Is the Mammographic X-Ray System Athena single-use or reusable, and what does that mean for maintenance?

  The Mammographic X-Ray System Athena is a reusable device, meaning it is not intended for single-use. This implies that it requires regular cleaning, maintenance, and calibration to ensure consistent performance and safety over time. Reusable systems are typically used in clinical settings where multiple patients are imaged.

• How is the Mammographic X-Ray System Athena supplied, and what should be considered when storing it?

  The Mammographic X-Ray System Athena is supplied as a non-sterile, reusable medical device. Since it is not sterile, it should not be used in procedures requiring sterile conditions. Storage should be in a clean, dry environment, protected from physical damage and environmental contaminants, and following manufacturer guidelines to maintain optimal functionality.

• What regulatory pathway was followed for FDA clearance of the Mammographic X-Ray System Athena, and what does this mean for its use?

  The Mammographic X-Ray System Athena received FDA 510(k) clearance under K-number K880531, following a traditional review process by the Radiology Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the U.S. without additional approvals beyond this clearance.