K250928
- 510(k) number
- K250928
- Device name
- OmniTom Elite with PCD
- Applicant
- Neurologica Corporation MA · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-09-08
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250928.pdf
Official FDA record: K250928
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.