RAPIDSCREEN RS-2000D
FDA premarket approval P000041/S001 · decided 2003-06-30
Approval details
- PMA number
- P000041
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAPIDSCREEN RS-2000D
- Generic name
- Analyzer, medical image
- Applicant
- Riverain Medical Group
- Date received
- 2003-02-13
- Decision date
- 2003-06-30
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Miamisburg, OH
- 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 C
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SOFTVIEW, MODEL 2.01 (K092363) | Riverain Medical Group | 2010-03-18 |