Cleared Traditional

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

K220700 · Yian Medical Technology (Haining) Co., Ltd. · Radiology

May 2022

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K220700 is an FDA 510(k) clearance for the Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Yian Medical Technology (Haining) Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on May 4, 2022, 55 days after receiving the submission on March 10, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K220700 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2022
Decision Date	May 04, 2022
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF