Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P970058 |
Supplement Number | S022 |
Date Received | 11/28/2005 |
Decision Date | 06/23/2006 |
Reclassified Date
|
02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF NEW LABELING THAT WILL PRESENT THE SPECIFICITY OF CAD MARKS GENERATED BY R2 IMAGECHECKER COMPUTER AIDED DETECTION SYSTEM AS WELL AS ITS ABILITY TO MARK ACTIONABLE PRIORS. THE INDICATIONS FOR USE REMAIN AS PREVIOUSLY APPROVED: THE IMAGECHECKER M5000 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, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW. |
|
|