RAPIDSCREEN RS-2000
FDA premarket approval P000041 · decided 2001-07-12
Approval details
- PMA number
- P000041
- Trade name
- RAPIDSCREEN RS-2000
- Generic name
- Analyzer, medical image
- Applicant
- Riverain Medical Group
- Date received
- 2000-10-10
- Decision date
- 2001-07-12
- Days to decision
- 275 days
- Decision code
- APRL
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- Yes
- Location
- Miamisburg, OH
- Statement
- APPROVAL FOR THE RAPIDSCREEN(TM) RS-2000. THE DEVICE IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITIZED 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 USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SOFTVIEW, MODEL 2.01 (K092363) | Riverain Medical Group | 2010-03-18 |