BD FOCALPOINT GS IMAGING SYSTEM
FDA premarket approval P950009/S008 · decided 2008-12-03
Approval details
- PMA number
- P950009
- Supplement
- S008
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD FOCALPOINT GS IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2007-10-02
- Decision date
- 2008-12-03
- Days to decision
- 428 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FORTHE BD FOCALPOINT GS IMAGING SYSTEM. THIS DEVICE IS INDICATED TO ASSIST IN CERVICAL CANCERSCREENING OF BD SUREPATH PAP TEST SLIDES TO DETECT EVIDENCE OF SQUAMOUS CARCINOMA,ADENOCARCINOMA, AND THEIR USUAL PRECURSOR CONDITIONS. THESE SLIDES WILL BE RANKED ACCORDING TOTHE LIKELIHOOD OF ABNORMALITY, AND PROVIDE RELOCATION AND VISUAL REVIEW OF UP TO 10 FIELDS OF VIEW(FOVS) MOST LIKELY TO CONTAIN ABNORMAL CELLS. ADDITIONALLY, THE SYSTEM IDENTIFIES AT LEAST 15% OFALL SUCCESSFULLY PROCESSED
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