Product code MNM
- Device name
- Reader, Cervical Cytology Slide, Automated
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P950009S026 | BD FocalPoint GS Imaging System | Bd Diagnostics | 2022-07-11 |
| P950009S025 | BD FocalPoint GS Imaging System | Bd Diagnostics | 2021-11-23 |
| P950009S024 | BD FocalPoint GS Imaging System | Bd Diagnostics | 2021-03-29 |
| P950009S023 | BD FocalPoint GS Imaging System | Bd Diagnostics | 2019-12-06 |
| P950009S022 | BD FocalPoint GS Imaging System | Bd Diagnostics | 2019-09-05 |
| P950039S036 | ThinPrep Integrated Imager | Hologic, Inc. | 2018-04-18 |
| P950009S021 | BD FOCALPOINT GS IMAGING SYSTEM | Bd Diagnostics | 2016-06-17 |
| P950009S020 | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM | Bd Diagnostics | 2016-04-19 |
| P950009S018 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2016-02-12 |
| P950009S019 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2015-07-23 |
| P020002S010 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2015-06-02 |
| P020002S009 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2015-01-12 |
| P020002S008 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2014-09-18 |
| P020002S007 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2014-04-29 |
| P950009S017 | BD FOCAL POINT SLIDE PROFILER | Bd Diagnostics | 2014-02-26 |
| P950009S015 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2013-09-13 |
| P950009S016 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2012-08-30 |
| P950009S014 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2012-03-09 |
| P020002S006 | REVIEW SCOPE MANUAL | Hologic, Inc. | 2012-01-23 |
| P950009S013 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2011-11-10 |
| P950009S012 | BD FOCALPOINT GS IMAGING SYSTEM | Bd Diagnostics | 2010-09-16 |
| P020002S005 | THINPREP IMAGING SYSTEM LABELING | Hologic, Inc. | 2010-09-16 |
| P950009S010 | BD FOCALPOINT GS IMAGING SYSTEM | Bd Diagnostics | 2010-03-15 |
| P950009S011 | BD FOCALPOINT SLIDE PROFILER | Bd Diagnostics | 2010-01-08 |
| P950009S009 | BD FOCALPOINT SYSTEM | Bd Diagnostics | 2009-07-24 |
| P950009S008 | BD FOCALPOINT GS IMAGING SYSTEM | Bd Diagnostics | 2008-12-03 |
| P020002S003 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2007-08-30 |
| P020002S002 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2006-04-28 |
| P020002S001 | THINPREP IMAGING SYSTEM | Hologic, Inc. | 2005-06-08 |
| P020002 | THINPREP (R) IMAGING SYSTEM | Hologic, Inc. | 2003-06-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00382904914905 | BD™ FocalPoint™ Slide Profiler Refurbished | BECTON, DICKINSON AND COMPANY | 2023-09-08 |
| 15420045515062 | ThinPrep Imaging System | Hologic, Inc. | 2022-08-24 |
| 15420045513716 | Thinprep Imaging System | Hologic, Inc. | 2020-06-24 |
| 00382904914646 | BD FocalPoint Slide Profiler | BECTON, DICKINSON AND COMPANY | 2019-12-03 |
| 15420045512511 | ThinPrep Imaging System | Hologic, Inc. | 2019-12-03 |
| 15420045512535 | ThinPrep Imaging System | Hologic, Inc. | 2019-12-03 |
| 00382904910907 | BD FocalPoint™ Slide Profiler Refurbished | BECTON, DICKINSON AND COMPANY | 2019-06-27 |
| 15420045508156 | ThinPrep Imaging System | Hologic, Inc. | 2018-10-13 |
| 15420045508040 | ThinPrep Imaging System | Hologic, Inc. | 2018-05-23 |
| 15420045507265 | ThinPrep Imaging System | Hologic, Inc. | 2017-02-23 |
| 15420045507258 | ThinPrep Imaging System | Hologic, Inc. | 2017-02-23 |
| 15420045504103 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-22 |
| 15420045504035 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-22 |
| 15420045504097 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-08 |
| 15420045504080 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-08 |
| 15420045504042 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-08 |
| 15420045501034 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500891 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045501041 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500907 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045501027 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045501010 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045501003 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500990 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500983 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500976 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500945 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500938 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500921 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |
| 15420045500914 | ThinPrep Imaging System | Hologic, Inc. | 2014-09-02 |