Approval for the use of the imagechecker m1000 with input from the general electric medical systems' senographe 2000 full field digital mammography system.
| Device | IMAGE CHECKER (CAD) SYSTEM, M100 |
| Generic Name | Analyzer, Medical Image |
| Applicant | HOLOGIC, INC. |
| Date Received | 2001-09-28 |
| Decision Date | 2001-11-13 |
| PMA | P970058 |
| Supplement | S011 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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