EXABLATE 2000
FDA premarket approval P040003/S002 · decided 2007-02-27
Approval details
- PMA number
- P040003
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXABLATE 2000
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Applicant
- Insightec, Ltd.
- Date received
- 2006-07-17
- Decision date
- 2007-02-27
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- NRZ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Dallas, TX
- Statement
- APPROVAL TO IMPLEMENT THE VERSION 4.2 SOFTWARE AND A NEW PATIENT TABLE (WITH OTHER RELATED HARDWARE) THAT ALLOW FOR OPERATION OF THE EXABLATE 2000 SYSTEM WITH THE GENERAL ELECTRIC 3T MAGNETIC RESONANCE IMAGING (MRI) SYSTEM. VERSION 4.2 SOFTWARE PROVIDES FOR AN INTERLEAVED MODE OF OPERATION, ELONGATED FOCAL SPOTS, AND A SCALE-ABLE COOLING DURING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |