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510(k) K220700

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine by Yian Medical Technology (Haining) Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2022
Date Received
March 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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