IMAGECHECKER M1000

FDA premarket approval P970058/S012 · decided 2002-02-11

Approval details

PMA number

P970058

Supplement

S012

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

IMAGECHECKER M1000

Generic name

Analyzer, medical image

Applicant

Hologic, Inc.

Date received

2002-02-05

Decision date

2002-02-11

Days to decision

6 days

Decision code

APPR

Product code

MYN

Advisory committee

Radiology

Expedited review

No

Location

Bedford, MA

Statement

APPROVAL FOR A CHANGE TO THE NEW EFFICACY CLAIM IN PMA SUPPLEMENT 7 (VERSION 2.2 SOFTWARE). THE CHANGE IS FROM: "FOR EVERY 100,000 CANCERS CURRENTLY DETECTED BY SCREENING MAMMOGRAPHY, THE USE OF THE IMAGECHECKER COULD RESULT IN EARLY DETECTION OF AN ADDITIONAL 30,500 BREAST CANCERS." TO: "USE OF THE IMAGECHECKER COULD RESULT IN EARLIER DETECTION OF UP TO 23.4% (95% CI, 19.4% - 27.4%) OF THE CANCERS CURRENTLY DETECTED WITH SCREENING MAMMOGRAPHY IN THOSE WOMEN WHO HAD A PRIOR SCREENING MAMMOGRAM 9

510(k) clearances by this applicant