510(k) K212116
K212116 is an FDA 510(k) premarket notification submitted by Vysioneer, Inc. for the device "VBrain-OAR". The FDA issued a decision of Substantially Equivalent on Oct 12, 2021. The device falls under product code QKB (Radiological Image Processing Software For Radiation Therapy), a Class II device regulated under 21 CFR 892.2050. Vysioneer, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2021
- Date Received
- Jul 7, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Image Processing Software For Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.