Cleared Traditional

K202808 - Brainance MD (FDA 510(k) Clearance)

K202808 · Advantis Medical Imaging Single Member P.C. · Radiology device

Oct 2021

Decision

386d

Days

Class 2

Risk

K202808 is an FDA 510(k) clearance for the Brainance MD. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Advantis Medical Imaging Single Member P.C. (Athens, GR). The FDA issued a Cleared decision on October 14, 2021, 386 days after receiving the submission on September 23, 2020.

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

Submission Details

510(k) Number	K202808 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 2020
Decision Date	October 14, 2021
Days to Decision	386 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF