| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | M1000 IMAGECHECKER |
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| Generic Name | Analyzer, medical image |
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| Regulation Number | 892.2070 |
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| Applicant | HOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730 |
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| PMA Number | P970058 |
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| Date Received | 12/16/1997 |
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| Decision Date | 06/26/1998 |
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| Reclassified Date | 02/21/2020 |
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| Product Code |
MYN |
| Docket Number | 98M-0618 |
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| Notice Date | 08/12/1998 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
The Image Checker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them tot he attention of the radiologist after the initial readin ghas 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. |
| Supplements: |
S022 S009 S014 S015 S016 S001 S002 S004 S005 S006 S007 S017
S011 S020 S010 S024 S008 S012 S013 S003 S025 S027 S021 S018
S019 S026 |
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