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Exablate (2100V1 +3 more) - Exablate 2100V1 Type 3.0
FDA 510(k)Class II (US FDA 510(k))
510(k) K231378
Identifiers
- 510(k) Number
- K231378 FDA 510(k)
- FDA Product Code
- PLP FDA 510(k)
- Models / Variants
- 2100V1 FDA 510(k)Exablate Prostate System FDA 510(k)Exablate MRgFUS FDA 510(k)Exablate 2100V1 Type 3.0 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4340 FDA 510(k)
- Regulation Number
- 876.4340 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Exablate (2100V1 +3 more) - Exablate 2100V1 Type 3.0 by Insightec Ltd — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231378 | Class II | Active |
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Manufacturer
- Manufacturer
- Insightec Ltd
- FDA Applicant
- Insightec, Ltd.
Sources (1)
- FDA 510(k) K231378 24 fields · synced Jun 18, 2026