Imaging system of positron emission and X-ray computed tomography (DigitMI 930)— 510(k) K241266

Name: FDA 510(k) clearance K241266
Creator: U.S. Food and Drug Administration
Published: 2025-01-27

Substantially Equivalent

Raysolution Healthcare Co., Ltd.

FDA 510(k) clearance K241266 for Imaging system of positron emission and X-ray computed tomography (DigitMI 930), Substantially Equivalent on 2025-01-27. Applicant: Raysolution Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Raysolution Healthcare Co., Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2024-05-06
Decision date: 2025-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hefei, CN

Download summary PDF View on FDA.gov ↗

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