Name: Predicase
Price: 199 USD

K-number	K202350
Device name	SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
Applicant	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code	IZL
Device class	Class II
Decision date	Jan 6, 2021
Decision	Substantially Equivalent
Regulation	892.1720

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Source

View the full FDA submission: accessdata.fda.gov

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SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

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