Identity
- Trade Name
- 7290019402558 FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Device Name
- Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue. FDA UDI
- Model / Reference
- 4000 Type 1.1 FDA UDI
- Description
- Transcranial, magnetic resonance, image-guided focused ultrasound (MRgFUS) system that is designed for Incisionless ablation of brain tissue. FDA UDI
Identifiers
- Catalog Number
- SYS004000-CA FDA UDI
- Primary DI / UDI-DI
- 07290019402558 FDA UDI
- PMA Number
- P150038 FDA UDI
- FDA Product Code
- POH FDA UDI
- GMDN Term
- Ultrasonic hyperthermia system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Ultrasonic hyperthermia system
7290019402558 by Insightec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Insightec
Sources (1)
- FDA UDI 0d11303a-9713-44ab-9ceb-3383159289f4 37 fields · synced Jun 6, 2026