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. |
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Device | IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1) |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P970058 |
Supplement Number | S018 |
Date Received | 10/22/2003 |
Decision Date | 11/26/2003 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF THE IMAGECHECKER SYSTEM WITH THE FISCHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER D (DIGITAL MAMMOGRAPHY ONLY), IMAGECHECKER DM (DIGITAL AND ANALOG MAMMOGRAPHY), AND IMAGECHECKER OEM-D (DIGITAL MAMMOGRAPHY ONLY, SOLD BY FFDM VENDOR). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.1. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER D/DM.OEM-D 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. |
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