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Sign in to claim this brandWhat Insightec makes
The company manufactures focused ultrasound systems designed for therapeutic applications in oncology and gynaecology, including devices for targeted tissue ablation and hyperthermia. These systems are used with MRI-compatible coils and patient treatment kits for procedures such as tumour ablation and uterine fibroid reduction. Additional accessories include phantom gels for calibration, head frames, and MRI-compatible neuro kits for neurosurgical applications. The portfolio also includes RF coils and master treatment kits tailored for specific MRI platforms.
The devices fall under FDA-regulated classifications, with some authorised as Class II and others as Class III. They are listed under the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) programs. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Insightec manufacture?
Insightec specialises in focused ultrasound systems primarily used for therapeutic purposes in oncology and gynaecology. These include devices designed for targeted tissue ablation and hyperthermia, such as the ExAblate system, which is often paired with MRI-compatible coils and patient treatment kits. The company also produces accessories like phantom gels for calibration, head frames, and MRI-compatible neuro kits for neurosurgical applications. These systems are intended for procedures like tumour ablation and uterine fibroid reduction.
Where is Insightec based?
Insightec is headquartered in the United States. The company’s location influences its regulatory compliance, particularly with the FDA, which oversees the authorisation of its medical devices.
Which regulatory registries list Insightec’s devices?
Insightec’s devices are listed under the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) programs. These registries ensure traceability and compliance tracking for devices authorised under Class II and Class III classifications, which are common for its therapeutic ultrasound systems.
How are Insightec’s devices classified by regulatory authorities?
Insightec’s devices fall under FDA-regulated classifications, specifically Class II and Class III. Class III is typically reserved for higher-risk devices, such as those used in life-supporting or life-sustaining applications or those intended for surgical procedures. The classification determines the regulatory pathway for authorisation, with Class III devices requiring Premarket Approval (PMA) due to their higher risk profile.
What is the primary purpose of Insightec’s therapeutic ultrasound systems?
The primary purpose of Insightec’s therapeutic ultrasound systems is to deliver focused ultrasound energy for non-invasive or minimally invasive tissue ablation and hyperthermia. These systems are designed to target specific tissues, such as tumours or uterine fibroids, with precision while sparing surrounding healthy tissue. The integration with MRI-compatible coils and patient-specific kits ensures accurate treatment delivery during procedures.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (83)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neuro Kit 3T for USA | Neuro Kit 3T for USA | FDA UDI | Class III | Active |
| Head Ring Screws Short | MPR000445-AA HEAD RING SCREWS SHORT | FDA UDI | Class III | Active |
| Ex Neuro Patient Treatment Kit 3.0t W\o Coil | SET001117 (w/ PFK) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL | FDA UDI | Class III | Active |
| ExAblate 2100 LOWER PELVIC COIL ASSEMBLY | ASM000506-AA ExAblate 2100 LOWER PELVIC COIL ASSEMBLY | FDA UDI | Class III | Active |
| 7290019402558 | 4000 Type 1.1 | FDA UDI | Class III | Active |
| Head Ring Screws Long | MPR000444-AA HEAD RING SCREWS LONG SET | FDA UDI | Class III | Active |
| water bag kit | water bag kit | FDA UDI | Class III | Active |
| Neuro Protective Frame Pin Cup | Neuro Protective Frame Pin Cup | FDA UDI | Class III | Active |
| EXABLATE PROSTATE Treatment master kit for V2.2 | PROSTATE WATERLESS MASTER KIT FOR 5 TREATMENTS (FDA/NON-CE) | FDA UDI | Class II | Active |
| Neuro-V2 Patient 1.5t Treat. Kits Master Set | SET001026-BB MASTER SET NEURO V2 PATIENT TREAT.KITS 1.5T | FDA UDI | Class III | Active |
| Headframe Pfk Type 1.1 Fda/Row Integra (fmi) | SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) | FDA UDI | Class III | Active |
| Neuro-V1 3t Treat. Kits (5 X Set400314) Master Set | SET001025 MASTER SET NEURO-V1 3T TREAT. KITS (5 X SET400314) | FDA UDI | Class III | Active |
| ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MR | OPT000037-AR ExAblate 2100V1 Pelvic RF Coil for Body | FDA UDI | Class III | Active |
| Neuro V2 Kit 3T for USA | SET000960-AA Neuro V2 Kit 3T for USA | FDA UDI | Class III | Active |
| Neuro Stereotactic Frame Set | Neuro Stereotactic Frame Set | FDA UDI | Class III | Active |
| Neuro Kit 1.5T for USA | SET000937-AA Neuro Kit 1.5T for USA | FDA UDI | Class III | Active |
| Head Frame Set for Type 1.1 Systems FDA/ROW | SET400168-BD Head Frame Set for Type 1.1 Systems FDA/ROW | FDA UDI | Class III | Active |
| Neuro membrane | neuro membrane | FDA UDI | Class III | Active |
| Head Ring Screws Long | HEAD RING SCREWS LONG | FDA UDI | Class III | Active |
| Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA | SET001101 Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA | FDA UDI | Class III | Active |
| Exablate Neuro Treatment Accessories Kit | Exablate 4000 | FDA UDI | Class III | Active |
| Exablate Neuro Patient Treatment Kit 1.5t Si | SET001116 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI | FDA UDI | Class III | Active |
| Neuro V2 1.5t Si Coil Patient Accessories Set | SET400315-BB NEURO V2 1.5T SI COIL PATIENT ACCESSORIES SET | FDA UDI | Class III | Active |
| Exablate Neuro Patient Treatment Kit 1.5t Si (5) Non-Ce | SET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) NON-CE | FDA UDI | Class III | Active |
| 1L degasseed water pouch | 1L degasseed water pouch | FDA UDI | Class III | Active |
| Neuro Stereotactic Frame | Neuro Stereotactic Frame | FDA UDI | Class III | Active |
| Exablate Neuro V2 | SYS0004000-BA 4000 Type 1.1 | FDA UDI | Class III | Active |
| Exablate Neuro | 4000 Type 1.0 | FDA UDI | Class III | Active |
| NEURO PATIENT TREAT.KITS 1.5T MASTER SET for USA | SET000973 NEURO PATIENT TREAT.KITS 1.5T MASTER SET | FDA UDI | Class III | Active |
| Ex Neuro Patient Treatment Kit 3.0t W\o Coil (5) Non-Ce | SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE | FDA UDI | Class III | Active |
| Exablate Prostate System | K212150 | FDA 510(k) | Class II | Active |
| Exablate Model 4000 System | P150038 | FDA PMA | Class III | Active |
| Exablate | P110039 | FDA PMA | Class III | Active |
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