510(k) K230082
K230082 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Auto Segmentation". The FDA issued a decision of Substantially Equivalent on May 4, 2023. The device falls under product code QKB (Radiological Image Processing Software For Radiation Therapy), a Class II device regulated under 21 CFR 892.2050. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2023
- Date Received
- January 11, 2023
- 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.