Monaco RTP System (6.3)— 510(k) K252002
Substantially EquivalentElekta Solutions AB
FDA 510(k) clearance K252002 for Monaco RTP System (6.3), Substantially Equivalent on 2026-02-19. Applicant: Elekta Solutions AB. Device class: 2.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
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