510(k) K220408

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

November 10, 2022

Date Received

February 14, 2022

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.