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Sign in to claim this brandINSIGHTEC LTD
Israel·IL-MF-000011795
Last updated May 24, 2026
What INSIGHTEC LTD makes
Insightec Ltd manufactures gel pads for ultrasound-guided procedures, including a standard 15mm pad and a larger 45mm bowl-shaped variant, as well as water treatment kits for therapeutic applications. Their portfolio includes focused ultrasound systems, such as the Exablate 2100V1 and Exablate Prostate System, designed for non-invasive tissue ablation, alongside accessories like the Exablate Scar Patch for post-treatment care. Additional devices include the Exablate MRgFUS system for MRI-guided focused ultrasound and the Exablate 2000 System, specifically for uterine fibroid ablation.
The company’s products span Class I, Class II, and Class III medical devices under global regulatory frameworks, with listings in the EU’s EUDAMED database, the FDA’s 510(k) and PMA clearance registries. These systems are intended for use in procedures requiring precise ultrasound energy delivery, often under MRI guidance, and are authorised for commercial distribution in markets adhering to these regulatory standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Israel
- Address
- 5, Nachum Heth, Tirat Carmel, Israel
- —
- —
- [email protected]
- Phone
- 18663922528
- PRRC Contact
- Dorit Nahari
- EUDAMED SRN
- IL-MF-000011795
- FDA FEI Number
- —
- DUNS Number
- 532169513
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gel Pad 15mm | ASM000830-AA-CE | EUDAMED | Class I | Active |
| Gel Pad 45mm (bowl) | ASM000504-AA-CE | EUDAMED | Class I | Active |
| 3 Treatment Water Kit | SET000841-CE | EUDAMED | Class I | Active |
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | K231378 | FDA 510(k) | Class II | Active |
| Exablate Scar Patch | SET000554-CE | EUDAMED | Class I | Active |
| Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids | P040003 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
- Obelis s.a. BE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Insightec US