PMA P000041S005

Device: RAPIDSCREEN RS-2000D
Applicant: Riverain Medical Group
PMA number: P000041
Supplement: S005
Product code: MYN
Decision date: 2006-11-01
Generic name: Analyzer, medical image
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.

Current openFDA PMA Record#

Device: RAPIDSCREEN RS-2000D
Applicant: Riverain Medical Group
PMA number: P000041
Supplement: S005
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2006-11-01
Decision code: APPR
Date received: 2006-07-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.