Name: Predicase
Price: 199 USD

K-number	K223028
Device name	uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Applicant	Shanghai United Imaging Healthcare Co., Ltd.
Product code	JAK
Device class	Class II
Decision date	Feb 16, 2023
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

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