| 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 | RAPIDSCREEN RS-2000 |
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| Generic Name | analyzer, medical image |
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| Regulation Number | 892.2070 |
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| Applicant | RIVERAIN MEDICAL GROUP
3020 south tech blvd.
miamisburg, OH 45342-4860 |
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| PMA Number | P000041 |
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| Date Received | 10/10/2000 |
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| Decision Date | 07/12/2001 |
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|
Reclassified Date
|
02/21/2020 |
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| Product Code |
MYN |
| Docket Number | 01M-0306 |
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| Notice Date | 07/23/2001 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE RAPIDSCREEN(TM) RS-2000. THE DEVICE IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITIZED FRONTAL CHEST RADIOGRAPHS. IT IDENTIFIES FEATURES ASSOCIATED WITH SOLITARY PULMONARY NODULES FROM 9 TO 30 MM IN SIZE, WHICH COULD REPRESENT EARLY-STAGE LUNG CANCER. THE DEVICE IS INTENDED FOR USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S003 S005 S006 S009 S010 S011 |
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