RefleXion Medical Radiotherapy System, Reflexion X2— 510(k) K252071
Substantially EquivalentReflexion Medical, Inc.
FDA 510(k) clearance K252071 for RefleXion Medical Radiotherapy System, Reflexion X2, Substantially Equivalent on 2025-12-18. Applicant: Reflexion Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Reflexion Medical, Inc.
- Product code
- Code QVA
- Device class
- Class 2
- Regulation
- 21 CFR 892.5060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
Recent devices under product code QVA
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