K253450
- 510(k) number
- K253450
- Device name
- BodyTom Elite (NL4000)
- Applicant
- NeuroLogica Corp., a Samsung Company MA · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2026-07-28
- Date received
- 2025-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253450.pdf
Official FDA record: K253450
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.