K241266
- 510(k) number
- K241266
- Device name
- Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
- Applicant
- Raysolution Healthcare Co., Ltd. CN
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-01-27
- Date received
- 2024-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K241266.pdf
Official FDA record: K241266
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.