M1000 Imagechecker

FDA premarket approval P970058 · Analyzer, medical image

PMA numberP970058

Approval

Applicant
Hologic, Inc.
Received
December 16, 1997
Decision date
June 26, 1998 (APRL)
Supplements
26, latest April 26, 2016
Product code
MYN – Analyzer, Medical Image

Official FDA PMA record

Approval order statement

The Image Checker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them tot he attention of the radiologist after the initial readin ghas been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.