510(k) K212218
K212218 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "Advanced Algorithms for Treatment Management Applications (AATMA)". The FDA issued a decision of Substantially Equivalent on October 25, 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. Elekta Solutions AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2021
- Date Received
- July 16, 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
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.