Giotto HT Mammographic X-Ray System

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

Full name

Giotto Ht

510(k) Number

K973856 ↗

FDA Product Code

IZH

Device Class

Class II

Regulation

21 CFR Part 892.1710

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Nuquest Nuclear Medicine Computer

  Class II

  FDA 510(k) K953255 Active Cleared 24 Oct 1995

• Biopsy-Digit

  Class II

  FDA 510(k) K990192 Active Cleared 12 Mar 1999

• Biopsy M

  Class II

  FDA 510(k) K982049 Active Cleared 14 Jul 1998

• What is the Giotto HT intended for?

  The Giotto HT is a mammographic X-ray system designed for digital or analog breast imaging, intended for high-resolution imaging of breast tissue to detect abnormalities such as calcifications, masses, or architectural distortions.

• Is the Giotto HT supplied as a sterile or non-sterile device?

  The Giotto HT is supplied as a reusable medical system and is not sterile; it requires proper maintenance and calibration per manufacturer guidelines for use in radiology departments or dedicated mammography facilities.

• What regulatory pathway was used for the Giotto HT, and what is its clearance status?

  The Giotto HT received FDA 510(k) clearance under K973856, with a decision description of 'Substantially Equivalent' and a clearance type of 'Traditional', indicating it was cleared through the traditional 510(k) process.

• What product code and regulation number apply to the Giotto HT?

  The Giotto HT is classified under product code IZH and is subject to regulation number 21 CFR 892.1710, which governs mammographic X-ray systems.

• Does the Giotto HT include MRI safety information in its labeling?

  No MRI safety information is specified for the Giotto HT in the provided data, so its safety in MRI environments is not addressed and must be evaluated separately according to local radiation safety protocols.