PARASCRIPT ACCUDETECT 6.1.0
FDA premarket approval P120004 · decided 2013-08-22
Approval details
- PMA number
- P120004
- Trade name
- PARASCRIPT ACCUDETECT 6.1.0
- Generic name
- Analyzer, medical image
- Applicant
- Parascript, LLC
- Date received
- 2012-03-30
- Decision date
- 2013-08-22
- Days to decision
- 510 days
- Decision code
- APRL
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Longmont, CO
- Statement
- APPROVAL FOR THE PARASCRIPT® ACCUDETECT® 6.1.0. THIS DEVICE IS INDICATED FOR USE IN SCREENING MAMMOGRAPHY TO IDENTIFY AREAS SUSPICIOUS FOR BREAST CANCER FOR RADIOLOGIST REVIEW AFTER COMPLETING AN INITIAL READ.
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