| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | M1000 IMAGECHECKER |
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| Classification Name | analyzer,medical image |
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| Generic Name | image analysis system |
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| Applicant | HOLOGIC, INC. |
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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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| Product Code | |
| 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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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: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S018
S019 S020 S021 S022 S024 S025
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