33 devices · 19 companies · 2019 to 2026
Product code MUJ: System, Planning, Radiation Therapy Treatment
33 devices under product code MUJ, 2019 to 2026, from 19 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (31 of 33 here), the regulation, and MAUDE report counts by product code.
System, Planning, Radiation Therapy Treatment. 21 CFR 892.5050, Class II. MAUDE held 807 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| RadOncAIK253050 · 510(k) | Informai | Radiology | database entry | |
| syngo.via RT Image Suite VC10K252304 · 510(k) | Varian Medical Systems, Inc. | Radiology | database entry | |
| Monaco RTP SystemK252002 · 510(k) | Elekta Solutions AB | Radiology | database entry | |
| ART-Plan+K253091 · 510(k) | Therapanacea Sas | Radiology | database entry | |
| Dose+K250064 · 510(k) | Mvision AI Oy | Radiology | database entry | |
| RT ElementsK250440 · 510(k) | Brainlab AG | Radiology | database entry | |
| OncospaceK242748 · 510(k) | Oncospace, Inc. | Radiology | database entry | |
| RayStation 2023B, RayPlan 2023B, RayStation 2024K240398 · 510(k) | RaySearch Laboratories AB (PUBL) | Radiology | database entry | |
| ART-Plan+K242822 · 510(k) | Therapanacea SAS | Radiology | database entry | |
| syngo.via RT Image SuiteK232799 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| ART-PlanK234068 · 510(k) | Therapanacea SAS | Radiology | database entry | |
| ART-PlanK232479 · 510(k) | TheraPanacea | Radiology | database entry | |
| MOZI TPSK223724 · 510(k) | Manteia Technologies Co., Ltd. | Radiology | database entry | |
| Radiation Planning AssistantK222728 · 510(k) | University of Texas, MD Anderson Cancer Center | Radiology | database entry | |
| RayStation 12AK222312 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry | |
| OncospaceK222803 · 510(k) | Oncospace, Inc. | Radiology | database entry | |
| syngo.via RT Image SuiteK220783 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | database entry | |
| MRI PlannerK211841 · 510(k) | Spectronic Medical AB | Radiology | database entry | |
| RayStation 11BK220141 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry | |
| INT ContourK212274 · 510(k) | Carina Medical LLC | Radiology | database entry | |
| MRCAT Head & NeckK214081 · 510(k) | Philips Oy | Radiology | database entry | |
| RayStation 11.0K211867 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry | |
| AI SegmentationK211881 · 510(k) | Varian Medical Systems, Inc. | Radiology | database entry | |
| syngo.via RT Image SuiteK211379 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | database entry | |
| RayStation 10.1K210645 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry | |
| AI SegmentationK203469 · 510(k) | Varian Medical Systems, Inc. | Radiology | database entry | |
| OncospaceK202284 · 510(k) | Oncospace, Inc. | Radiology | database entry | |
| RayStationK200569 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry | |
| Syngo.via RT Image SuiteK201444 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| MRCAT brainK193109 · 510(k) | Philips Medical Systems MR Finland | Radiology | database entry | |
| Syngo.Via RT Image SuiteK192065 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| RayCare 2.3K191384 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry | |
| RayStationK190387 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | database entry |
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