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.
| Device | IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1) |
| Generic Name | Analyzer, Medical Image |
| Applicant | HOLOGIC, INC. |
| Date Received | 2003-10-22 |
| Decision Date | 2003-11-26 |
| PMA | P970058 |
| Supplement | S018 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970058 | | Original Filing |
| S027 |
2016-01-20 |
Normal 180 Day Track No User Fee |
| S026 |
2013-10-17 |
Normal 180 Day Track |
| S025 |
2012-02-06 |
Normal 180 Day Track |
| S024 |
2006-09-18 |
Normal 180 Day Track No User Fee |
| S023 | | |
| S022 |
2005-11-28 |
Normal 180 Day Track |
| S021 |
2004-11-19 |
Real-time Process |
| S020 |
2004-06-29 |
Normal 180 Day Track |
| S019 |
2004-03-01 |
Real-time Process |
| S018 |
2003-10-22 |
Real-time Process |
| S017 |
2003-07-08 |
Normal 180 Day Track |
| S016 |
2003-05-08 |
Normal 180 Day Track |
| S015 |
2002-10-22 |
Normal 180 Day Track |
| S014 |
2002-07-15 |
Normal 180 Day Track |
| S013 |
2002-02-19 |
Real-time Process |
| S012 |
2002-02-05 |
Normal 180 Day Track |
| S011 |
2001-09-28 |
Normal 180 Day Track |
| S010 |
2001-04-19 |
Normal 180 Day Track |
| S009 |
2000-12-08 |
Normal 180 Day Track |
| S008 |
2000-06-01 |
Normal 180 Day Track |
| S007 |
2000-01-28 |
Normal 180 Day Track |
| S006 |
2000-01-14 |
Normal 180 Day Track |
| S005 |
1999-09-08 |
Real-time Process |
| S004 |
1999-06-21 |
Normal 180 Day Track |
| S003 |
1998-12-16 |
Normal 180 Day Track |
| S002 |
1998-10-01 |
Normal 180 Day Track |
| S001 |
1998-09-29 |
Real-time Process |
NIH GUDID Devices