Data / Medical devices / Israel / Insightec, Ltd.
Insightec, Ltd.: FDA-registered device maker in TIRAT CARMEL Haifa, Israel, 2 510(k) clearances and 3 PMA approvals
Insightec, Ltd. is registered with the FDA (registration 9615058) in TIRAT CARMEL Haifa, Israel. It lists 4 device types. The FDA files 2 510(k) clearances and 3 PMA approvals under its listings, the newest dated October 30, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615058
- FEI number
- 3003105983
- Address
- 5 Nachum Heth ST., TIRAT CARMEL Haifa, Israel, 3912001
- Owner or operator
- INSIGHTEC (9039651)
- Roles
- Manufacturer
- First device listed
- November 12, 2007
- Registered through
- 2027
- Brand names listed
- ExAblate, Exablate Neuro, Exablate PRIME, Exablate Prostate System, P110039
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided | NRZ | 3 | Manufacturer | accessdata.fda.gov |
| High Intensity Ultrasound System For Prostate Tissue Ablation | PLP | 2 | Manufacturer | accessdata.fda.gov |
| Mr-Guided Focused Ultrasound System | POH | 3 | Manufacturer | accessdata.fda.gov |
| Ultrasound, Hyperthermia, Cancer Treatment | LSY | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2023 | K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | PLP | Substantially Equivalent | Insightec, Ltd. | accessdata.fda.gov |
| November 23, 2021 | K212150 | Exablate Prostate System | PLP | Substantially Equivalent | Insightec, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 11, 2016 | P150038 | EXABLATE | POH | 42 | September 16, 2026 | accessdata.fda.gov |
| October 18, 2012 | P110039 | EXABLATE | NRZ | 8 | August 16, 2018 | accessdata.fda.gov |
| October 22, 2004 | P040003 | EXABLATE 2000 SYSTEM | NRZ | 20 | July 23, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Mr-Guided Focused Ultrasound System
- All makers of High Intensity Ultrasound System For Prostate Tissue Ablation
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.