Cleared Traditional

TaiChiC

K203250 · Our United Corporation · Radiology

Mar 2021

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K203250 is an FDA 510(k) clearance for the TaiChiC, a System, Radiation Therapy, Radionuclide (Class II — Special Controls, product code IWB), submitted by Our United Corporation (Xi'An, CN). The FDA issued a Cleared decision on March 12, 2021, 128 days after receiving the submission on November 4, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5750.

Submission Details

510(k) Number	K203250 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2020
Decision Date	March 12, 2021
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF