RayCare (2024A SP1)— 510(k) K242992
Substantially EquivalentRaySearch Laboratories AB (PUBL)
FDA 510(k) clearance K242992 for RayCare (2024A SP1), Substantially Equivalent on 2025-04-17. 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
Recent devices under product code MUJ
view allMore clearances from RaySearch Laboratories AB (PUBL)
view allRecalls naming K242992
K-number listed on FDA's recall record- Z-2646-2026 — RayCare 2024A SP1. Oncology Information Systems.
- Z-2647-2026 — RayCare 2024A SP4. Oncology Information Systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242992.
Data sourced from openFDA. This site is unofficial and independent of the FDA.