Approval for the exablate 4000 type 1. 1 system, an expansion of the exablate 4000 type 1. 0 system to add compatibility with siemens 3t skyra, prisma and prismafit mr systems, including hardware changes to the devices helmet system, changes to the electronics of the devices front end cabinet, and changes to the device sub-systems required for connectivity with these siemens mri systems.
| Device | Exablate Model 4000 System |
| Classification Name | Mr-guided Focused Ultrasound System |
| Generic Name | Mr-guided Focused Ultrasound System |
| Applicant | InSightec |
| Date Received | 2018-02-20 |
| Decision Date | 2018-09-20 |
| PMA | P150038 |
| Supplement | S005 |
| Product Code | POH |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | InSightec 5 Nahum Heth Street tirat-hacarmet 39120 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150038 | | Original Filing |
| S024 |
2022-10-12 |
Normal 180 Day Track No User Fee |
| S023 |
2022-08-05 |
Real-time Process |
| S022 | | |
| S021 |
2022-03-10 |
Real-time Process |
| S020 |
2022-03-08 |
30-day Notice |
| S019 | | |
| S018 | | |
| S017 | | |
| S016 | | |
| S015 | | |
| S014 |
2021-03-31 |
Panel Track |
| S013 |
2020-10-23 |
Normal 180 Day Track |
| S012 |
2019-08-08 |
Normal 180 Day Track |
| S011 |
2019-03-26 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2018-07-23 |
Normal 180 Day Track |
| S007 |
2018-04-23 |
30-day Notice |
| S006 |
2018-03-07 |
Panel Track |
| S005 |
2018-02-20 |
Normal 180 Day Track |
| S004 |
2017-08-16 |
Normal 180 Day Track No User Fee |
| S003 |
2017-03-28 |
Normal 180 Day Track |
| S002 |
2017-01-17 |
Normal 180 Day Track |
| S001 |
2016-08-03 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices