Oncospace
510(k) K242748
Oncospace is a Class II device made by Oncospace, Inc., cleared under FDA 510(k) K242748 on 11 Apr 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242748 | Date11 Apr 2025 | StatusActive |
Official records
- FDA 510(k) database K242748
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242748
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Plan AI 1057 | 1057 | 05060608881574 | — | On the market |
Similar devices
Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).
- XPLAN 2.1 by Radionics, Inc.
- Monaco RTP System by ELEKTA SOLUTIONS AB
- RayStation 11B by RaySearch Laboratories AB (PUBL)
- Multimodality Simulation Workspace (MM Sim)1.0 728349 by Philips Medical Systems Nederland B.V.
- MRI Planner 3.0 M7104RT by GE Medical Systems, L.L.C.
- RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review by Brainlab AG
- syngo.via RT Image Suite by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Simuplan Treatment Planning System, Model V. 7.5 by Simuplan S.L.
- RayCare 2.3 by RaySearch Laboratories AB (PUBL)
- CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM by Accuray, Inc.