510(k) K250064
- Device
- Dose+ (1.0)
- Applicant
- Mvision AI OY
- 510(k) number
- K250064
- Product code
- MUJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-04
- Date received
- 2025-01-10
- Regulation
- 892.5050
- Classification name
- System, Planning, Radiation Therapy Treatment
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Kalpana Jha
- Address
- Paciuksenkatu 29 6th Floor Helsinki FI 00270 00270
FDA Registration Numbers
- 3030564015
- 3022745617
- 3016686005
- 3023344262
- 3008156050
- 3003793371
- 3009090417
- 3003873069
- 3014873236
- 3007037519
- 1038814
- 3016602874
- 3022719374
- 1651102
- 3000126629
- 3004580128
- 3011716550
- 3012039133
- 3042177665
- 9612186
- 3009077524
- 3018004899
- 3007791541
- 8043933
- 3002808157
- 3005136058
- 3025765259
- 3013410552
- 3033527281
- 3019543601
- 3007774465
- 3015232217
- 3003094912
- 3010123525
- 3003586672
- 2030598
- 3019834893
- 2939248
- 3014425747
- 3003768277
- 3004977335
- 2434141
- 3009302839
- 3006894636
- 3004561814
- 3004363352
- 3010034862
- 2916710
- 3025309924
- 3004608878
- 3003418325
- 9611894
- 3004555507
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code MUJ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026-05-14 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | 2025-06-17 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| K242748 | Oncospace | Oncospace, Inc. | 2025-04-11 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025-02-25 |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024-12-13 |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024-12-11 |