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IBA Proton Therapy System- Proteus 235 - Proteus TK2
FDA 510(k)Class II (US FDA 510(k))
510(k) K163500
Identifiers
- 510(k) Number
- K163500 FDA 510(k)
- FDA Product Code
- LHN FDA 510(k)
- Models / Variants
- Proteus One FDA 510(k)Proteus Plus FDA 510(k)Proteus TK2 FDA 510(k)Proteus Class FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
IBA Proton Therapy System- Proteus 235 - Proteus TK2 by Ion Beam Applications S.A. — Class II — FDA_510K — listed in FDA 510(k) — 4 models
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 | K163500 | Class II | Active |
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Manufacturer
- Manufacturer
- Ion Beam Applications S.A.
Sources (1)
- FDA 510(k) K163500 24 fields · synced Jun 18, 2026