PMA P950009S008
- Device
- BD FOCALPOINT GS IMAGING SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S008
- Product code
- MNM
- Decision date
- 2008-12-03
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order 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 SLIDES WITH THE BD FOCAL POINT SLIDE PROFILER* DIRECTED QCTECHNOLOGY FOR A DIRECTED QC RE-SCREEN. INTENDED USERS ARE TRAINED CYTOLOGY LABORATORYPERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORYMANAGER/DIRECTOR.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P950009S008B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- BD FOCALPOINT GS IMAGING SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S008
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2008-12-03
- Decision code
- APPR
- Date received
- 2007-10-02
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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 SLIDES WITH THE BD FOCAL POINT SLIDE PROFILER* DIRECTED QCTECHNOLOGY FOR A DIRECTED QC RE-SCREEN. INTENDED USERS ARE TRAINED CYTOLOGY LABORATORYPERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORYMANAGER/DIRECTOR.