RayStation (2024A SP3)— 510(k) K252109
Substantially EquivalentRaySearch Laboratories AB (PUBL)
FDA 510(k) clearance K252109 for RayStation (2024A SP3), Substantially Equivalent on 2025-12-22. Applicant: RaySearch Laboratories AB (PUBL). Device class: 2.
Clearance details
- Applicant
- RaySearch Laboratories AB (PUBL)
- 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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