Cleared Traditional

K193294 - AI-Rad Companion Engine (FDA 510(k) Clearance)

K193294 · Siemens Medical Solutions USA, Inc. · Radiology device

Jul 2020

Decision

226d

Days

Class 2

Risk

K193294 is an FDA 510(k) clearance for the AI-Rad Companion Engine. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on July 10, 2020, 226 days after receiving the submission on November 27, 2019.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K193294 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 27, 2019
Decision Date	July 10, 2020
Days to Decision	226 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF