This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for 1) software maintenance update to the currently approved clinical software (sw) versions 6. 24 (windows-xp)/6. 241 (windows-7) used in the exablate model 2100/ 2100v1 type 1. 1 / type 1. 11 system (referred to as exablate bone or the system). The new software revision will be version 6. 57 (windows-xp)/6. 58 (windows-7) (6. 57 is a set of enhancements to the sw; 6. 58 is an update to windows 7 os compatibility); and 2) addition of a water bag as an accessory for acoustic coupling. The water bag will be provided as an optional accessory to be used as an alternative to the previously-approved gel pad.
| Device | Exablate 2100/2100 VI System |
| Classification Name | Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided |
| Generic Name | Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided |
| Applicant | InSightec |
| Date Received | 2017-09-22 |
| Decision Date | 2018-01-25 |
| PMA | P110039 |
| Supplement | S008 |
| Product Code | NRZ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | General & Plastic Surgery |
| 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-carmel 39120 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110039 | Original Filing | |
| S010 | 2018-04-26 | Real-time Process |
| S009 | ||
| S008 | 2017-09-22 | Normal 180 Day Track |
| S007 | ||
| S006 | 2016-05-10 | Real-time Process |
| S005 | 2016-04-04 | Real-time Process |
| S004 | 2013-09-23 | Real-time Process |
| S003 | 2013-06-28 | Normal 180 Day Track No User Fee |
| S002 | 2012-11-06 | Normal 180 Day Track No User Fee |
| S001 | 2012-11-06 | Normal 180 Day Track No User Fee |