510(k) K211431

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 2, 2021

Date Received

May 7, 2021

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Automated Radiological Image Processing Software

Device Class

Class II

Regulation Number

892.2050

Review Panel

RA

Submission Type

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.