510(k) clearance
BodyTom 64 (NL4100); OmniTom Elite (NL5000)
- 510(k) number
- K261125
- Applicant
- Samsung HME America, Inc., dba NeuroLogica Corp.
- Decision date
- Sep 22, 2026
- Date received
- Apr 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JAK
- Device type
- System, X-Ray, Tomography, Computed
- Device class
- Class II
- Regulation
- 21 CFR 892.1750
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Danvers, MA, US