Name: Predicase
Price: 199 USD

K-number	K220700
Device name	Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
Applicant	Yian Medical Technology (Haining) Co., Ltd.
Product code	IZL
Device class	Class II
Decision date	May 4, 2022
Decision	Substantially Equivalent
Regulation	892.1720

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.