FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
RayCare 3.1
K Number: K200487
·
Decision Jun 10, 2020
Classifications
1
FEI Numbers
50
Registration Numbers
51
Same Product Code
243
Applicant Total
14
Review Days
104
Basic Information
- Device Name
- RayCare 3.1
- K Number
- K200487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RaySearch Laboratories AB (publ)
- Date Received
- February 27, 2020
- Decision Date
- June 10, 2020
- Product Code
- MUJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
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Other Clearances by RaySearch Laboratories AB (publ)
| K Number | Device Name | ||
|---|---|---|---|
| K242992 | RayCare (2024A SP1) | Apr 17, 2025 | Substantially Equivalent |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | Apr 4, 2025 | Substantially Equivalent |
| K222312 | RayStation 12A | Mar 29, 2023 | Substantially Equivalent |
| K220141 | RayStation 11B | Apr 15, 2022 | Substantially Equivalent |
| K211867 | RayStation 11.0 | Sep 8, 2021 | Substantially Equivalent |
| K210645 | RayStation 10.1 | Jun 29, 2021 | Substantially Equivalent |
| K200569 | RayStation | Sep 24, 2020 | Substantially Equivalent |
| K191384 | RayCare 2.3 | Jul 8, 2019 | Substantially Equivalent |
| K190387 | RayStation | Jun 19, 2019 | Substantially Equivalent |
| K180379 | RayStation 7 | Apr 25, 2018 | Substantially Equivalent |