Exablate 2100/2100V1 System
FDA premarket approval P040003/S021 · decided 2018-08-16
Approval details
- PMA number
- P040003
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate 2100/2100V1 System
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2018-04-26
- Decision date
- 2018-08-16
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- Approval for modification to the connector port between the MRI scanner and the ExAblate 2100/2100VI System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (K231378) | Insightec, Ltd. | 2023-10-30 |