Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RAPIDSCREEN RS-2000D |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | RIVERAIN MEDICAL GROUP 3020 SOUTH TECH BLVD. MIAMISBURG, OH 45342-4860 |
PMA Number | P000041 |
Supplement Number | S005 |
Date Received | 07/05/2006 |
Decision Date | 11/01/2006 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE RAPIDSCREEN RS-2000D TO PROVIDE REDUCED NUMBER OF FALSE POSITIVES PER IMAGE WITH A STATISTICALLY INSIGNIFICANT IMPACT ON THE DETECTION SENSITIVITY. |
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