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. |
|
Device | ICAD |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | ICAD, INC. 98 SPIT BROOK ROAD SUITE 100 NASHUA, NH 03062 |
PMA Number | P010038 |
Supplement Number | S002 |
Date Received | 10/28/2002 |
Decision Date | 11/20/2002 |
Reclassified Date
|
02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DEVICE NAME CHANGE FROM "MAMMOREADER" TO "ICAD." |
|
|