PMA P000041S001

Device: RAPIDSCREEN RS-2000D
Applicant: Riverain Medical Group
PMA number: P000041
Supplement: S001
Product code: MYN
Decision date: 2003-06-30
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR THE ADDITION OF THE ABILITY OF THE RAPIDSCREEN RS-2000D TO PROCESS DIGITAL IMAGES IN ADDITION TO FILM/SCREEN IMAGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RAPIDSCREEN RS-2000D AND IS INDICATED FOR: THE RS-2000D IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITAL OR DIGITALIZED 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 THE USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH.

Current openFDA PMA Record#

Device: RAPIDSCREEN RS-2000D
Applicant: Riverain Medical Group
PMA number: P000041
Supplement: S001
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2003-06-30
Decision code: APPR
Date received: 2003-02-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE ABILITY OF THE RAPIDSCREEN RS-2000D TO PROCESS DIGITAL IMAGES IN ADDITION TO FILM/SCREEN IMAGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RAPIDSCREEN RS-2000D AND IS INDICATED FOR: THE RS-2000D IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITAL OR DIGITALIZED 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 THE USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH.