RayStation 12A— 510(k) K222312
Substantially EquivalentRaySearch Laboratories AB (PUBL)
FDA 510(k) clearance K222312 for RayStation 12A, Substantially Equivalent on 2023-03-29. 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 K222312
K-number listed on FDA's recall record- Z-1105-2026 — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
- Z-2493-2025 — RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System.
- Z-1191-2025 — Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
- Z-1750-2024 — RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
- Z-1751-2024 — RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
- Z-1482-2024 — RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222312.
Data sourced from openFDA. This site is unofficial and independent of the FDA.