PMA P970058S016

Device: IMAGE CHECKER M1000 SYSTEM
Applicant: Hologic, Inc.
PMA number: P970058
Supplement: S016
Product code: MYN
Decision date: 2003-09-10
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR A NEW SOFTWARE RELEASE (V5.0) THAT: 1) PROVIDES THE USER WITH A CHOICE OF TWO OPERATING POINTS (ONE WITH HIGHER SENSITIVITY AND INCREASED FALSE MARKS AND THE OTHER WITH LOWER FALSE MARKS WITH DECREASED SENSITIVITY, CHOSEN AT THE TIME OF DEVICE INSTALLATION) FOR USE WITH FILM/SCREEN IMAGES ONLY; 2) WHEN PACKAGED WITH V3.1A SOFTWARE IN A SINGLE IMAGE CHECKER HOUSING, ALLOWS THE PROCESSING OF BOTH ANALOG AND GE FFDM IMAGES; 3) ALLOWS CAD PROCESSING OF GE FFDM DICOM IMAGES FORMATTED FOR PRESENTATION; AND 4) REDUCES THE NUMBER OF OVERSIZED MALIGNANT CALCIFICATION CLUSTERS MISSED BY EARLIER ALGORITHMS.

Current openFDA PMA Record#

Device: IMAGE CHECKER M1000 SYSTEM
Applicant: Hologic, Inc.
PMA number: P970058
Supplement: S016
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2003-09-10
Decision code: APPR
Date received: 2003-05-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW SOFTWARE RELEASE (V5.0) THAT: 1) PROVIDES THE USER WITH A CHOICE OF TWO OPERATING POINTS (ONE WITH HIGHER SENSITIVITY AND INCREASED FALSE MARKS AND THE OTHER WITH LOWER FALSE MARKS WITH DECREASED SENSITIVITY, CHOSEN AT THE TIME OF DEVICE INSTALLATION) FOR USE WITH FILM/SCREEN IMAGES ONLY; 2) WHEN PACKAGED WITH V3.1A SOFTWARE IN A SINGLE IMAGE CHECKER HOUSING, ALLOWS THE PROCESSING OF BOTH ANALOG AND GE FFDM IMAGES; 3) ALLOWS CAD PROCESSING OF GE FFDM DICOM IMAGES FORMATTED FOR PRESENTATION; AND 4) REDUCES THE NUMBER OF OVERSIZED MALIGNANT CALCIFICATION CLUSTERS MISSED BY EARLIER ALGORITHMS.