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
FDA 510(k) clearance K250440 · decided 2025-06-17
Clearance details
- K-number
- K250440
- Device name
- 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
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2025-02-14
- Decision date
- 2025-06-17
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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| syngo.via RT Image Suite VC10 (K252304) | Varian Medical Systems, Inc. | 2026-03-18 |
| TrueFit Bolus (K260308) | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| Monaco RTP System (6.3) (K252002) | Elekta Solutions AB | 2026-02-19 |
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| RayStation (2024A SP3) (K252109) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| ClearCalc Model RADCA V2.6 (K252863) | Radformation, Inc. | 2025-12-19 |
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Recalls involving this device
No recalls on record reference this clearance.