K230220
- 510(k) number
- K230220
- Device name
- NeuViz 128 Multi-Slice CT Scanner System
- Applicant
- Neusoft Medical Systems Co., Ltd. CN
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-10-11
- Date received
- 2023-01-26
- 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: K230220.pdf
Official FDA record: K230220
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.