K233753
- 510(k) number
- K233753
- Device name
- AI-Rad Companion (Pulmonary)
- Applicant
- Siemens Healthcare GmbH DE
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-03-21
- Date received
- 2023-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233753.pdf
Official FDA record: K233753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.