K242811
- 510(k) number
- K242811
- Device name
- BodyTom 64
- Applicant
- Neurologica Corporation, A Subsidiary of Samsung MA · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-03-14
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242811.pdf
Official FDA record: K242811
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.