IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

FDA premarket approval P970058/S017 · decided 2003-11-25

Approval details

PMA number

P970058

Supplement

S017

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Generic name

Analyzer, medical image

Applicant

Hologic, Inc.

Date received

2003-07-08

Decision date

2003-11-25

Days to decision

140 days

Decision code

APPR

Product code

MYN

Advisory committee

Radiology

Expedited review

No

Location

Bedford, MA

Statement

APPROVAL FOR THE ADDITION OF A NEW DIGITIZER, THE VIDAR DIAGNOSTIC PRO FILM DIGITIZER AND NEW CAD SOFTWARE, VERSION 6.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMAGECHECKER LX AND IMAGECHECKER DX DEPENDING UPON OPTIONS CHOSEN. THE INDICATIONS ARE: THE IMAGECHECKER LX/DX IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS,

510(k) clearances by this applicant