Product code POH
- Device name
- Mr-Guided Focused Ultrasound System
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P150038S041 | EXABLATE | Insightec | 2026-03-23 |
| P150038S042 | Exablate Model 4000 Type 1.0 and 1.1 (“Exablate Neuro”; “Exablate Prime”) | Insightec | 2026-03-05 |
| P150038S043 | Exablate Model 4000 System | Insightec | 2026-01-28 |
| P150038S037 | Exablate Model 4000 Type-1 System | Insightec | 2025-07-03 |
| P150038S039 | Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) | Insightec | 2025-06-03 |
| P150038S040 | Exablate 4000; Exablate Transcarnial MRgFUS; Exablate Neuro; Exablate Prime; ExAblate Neuravive | Insightec | 2025-04-04 |
| P150038S038 | Exablate Model 4000 System | Insightec | 2025-04-04 |
| P150038S026 | Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) | Insightec | 2025-03-25 |
| P150038S036 | Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive | Insightec | 2024-10-08 |
| P150038S034 | Exablate | Insightec | 2024-02-27 |
| P150038S035 | Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro | Insightec | 2024-02-26 |
| P150038S033 | Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”) | Insightec | 2024-01-21 |
| P150038S032 | Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro) | Insightec | 2024-01-08 |
| P150038S025 | Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro) | Insightec | 2023-10-12 |
| P150038S031 | Exablate Model 4000 System | Insightec | 2023-07-27 |
| P150038S028 | Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav | Insightec | 2023-07-27 |
| P150038S027 | Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav | Insightec | 2023-07-27 |
| P150038S030 | Exablate Model 4000 System | Insightec | 2023-07-21 |
| P150038S029 | Exablate 4000 (Exablate Neuro) | Insightec | 2023-07-21 |
| P150038S015 | Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) | Insightec | 2023-07-18 |
| P150038S022 | Exablate 4000 System Type-1 (i.e. Type 1.0/1.1) | Insightec | 2022-12-08 |
| P150038S024 | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) | Insightec | 2022-11-11 |
| P150038S023 | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) | Insightec | 2022-11-02 |
| P150038S018 | Exablate Model 4000 Type 1.0 and 1.1 Systems | Insightec | 2022-07-29 |
| P150038S021 | Exablate 4000 (Exablate Neuro) | Insightec | 2022-06-07 |
| P150038S019 | Exablate Model 4000 System | Insightec | 2022-04-06 |
| P150038S020 | Exablate Model 4000 System | Insightec | 2022-03-31 |
| P150038S014 | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) | Insightec | 2021-10-29 |
| P150038S013 | Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) | Insightec | 2021-07-22 |
| P150038S010 | Exablate 4000 (“Neuro”) Type 1.0 & 1.1 | Insightec | 2020-11-09 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290019402565 | Exablate Neuro Treatment Accessories Kit | INSIGHTEC LTD | 2025-05-01 |
| 07290019402558 | 7290019402558 | INSIGHTEC LTD | 2025-01-01 |
| 07290019402442 | HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI) | INSIGHTEC LTD | 2023-06-26 |
| 07290019402466 | HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) | INSIGHTEC LTD | 2023-06-26 |
| 07290019402138 | EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU | INSIGHTEC LTD | 2022-12-15 |
| 07290019402121 | EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI | INSIGHTEC LTD | 2022-12-15 |
| 07290015461948 | HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20) | INSIGHTEC LTD | 2021-08-10 |
| 07290015461931 | HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20) | INSIGHTEC LTD | 2021-08-10 |
| 07290015461924 | INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET | INSIGHTEC LTD | 2021-08-10 |
| 07290015461917 | Low Height Head Frame Set NEURO-V2 (Inegra) | INSIGHTEC LTD | 2021-08-10 |
| 07290015461429 | Neuro V2 Kit 3T for USA | INSIGHTEC LTD | 2018-11-29 |
| 07290015461405 | NEURO V2 PATIENT TREAT.KITS 3T MASTER SET | INSIGHTEC LTD | 2018-11-29 |
| 07290015461238 | Neuro Patient Accessory Kit | INSIGHTEC LTD | 2017-07-31 |
| 07290015461245 | Neuro Helmet Sealant | INSIGHTEC LTD | 2017-07-31 |
| 07290015461337 | Neuro Frame Attachment Strap | INSIGHTEC LTD | 2017-07-31 |
| 07290015461283 | Neuro Stereotactic Frame Set | INSIGHTEC LTD | 2017-07-31 |
| 07290015461290 | Neuro Stereotactic Frame | INSIGHTEC LTD | 2017-07-31 |
| 07290015461306 | Neuro Protective Frame Pin Cup | INSIGHTEC LTD | 2017-07-31 |
| 07290015461313 | Neuro Stereotactic Frame Screws Set | INSIGHTEC LTD | 2017-07-31 |
| 07290015461320 | Neuro Stereotactic Frame Posts | INSIGHTEC LTD | 2017-07-31 |
| 07290015461160 | neuro cleaning kit for USA | INSIGHTEC LTD | 2017-06-30 |
| 07290015461276 | HEAD RING SCREWS SHORT | INSIGHTEC LTD | 2017-06-07 |
| 07290015461221 | HEAD RING SCREWS LONG | INSIGHTEC LTD | 2017-06-07 |
| 07290015461207 | NEURO DQA PHANTOM GEL | INSIGHTEC LTD | 2017-06-07 |
| 07290015461191 | NEURO TREATMENT ACCESSORIES KIT | INSIGHTEC LTD | 2017-06-07 |
| 07290015461184 | Neuro Head coil | INSIGHTEC LTD | 2017-06-07 |
| 07290015461177 | Neuro membrane | INSIGHTEC LTD | 2017-06-07 |
| 07290015461146 | Neuro Kit 1.5T for USA | INSIGHTEC LTD | 2017-06-07 |
| 07290015461122 | Neuro Kit 3T for USA | INSIGHTEC LTD | 2017-06-07 |
| 07290015461023 | EXABLATE NEURO | INSIGHTEC LTD | 2016-08-03 |