Mammoscan

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

510(k) Number

K923061 ↗

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 Mammoscan device used for?

  The Mammoscan is a System, X-Ray, Mammographic device intended for use in radiology settings to perform mammographic imaging, which is a specialized X-ray procedure for examining breast tissue to detect abnormalities such as tumors or calcifications.

• Who manufactures the Mammoscan and where is it made?

  The Mammoscan is manufactured by Fischer Imaging Corp., with manufacturing and registration facilities located in Denver, Colorado, United States, as indicated by the address 12300 N. Grant St., Denver, CO 80241.

• How was the Mammoscan cleared for market release?

  The Mammoscan received FDA 510(k) clearance through the traditional pathway on September 10, 1992, under K number K923061, after being found substantially equivalent to a predicate device in the same product code and regulation.

• What regulatory classification and product code apply to the Mammoscan?

  The Mammoscan is classified as a Class II medical device with product code IZH and is regulated under 21 CFR 892.1710, which covers mammographic X-ray systems, as confirmed in its FDA 510(k) documentation.