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.
Summary
Elekta Solutions' Monaco RTP System (6.3) is filed under product code MUJ, radiation therapy treatment planning system. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Elekta Solutions filed from Stockholm, Sweden. The decision came 237 calendar days after FDA received it (June 27, 2025 to February 19, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Product 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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