BodyTom 64 (NL4100); OmniTom Elite (NL5000)— 510(k) K261125
Substantially EquivalentSamsung HME America, Inc., dba NeuroLogica Corp.
FDA 510(k) clearance K261125 for BodyTom 64 (NL4100); OmniTom Elite (NL5000), Substantially Equivalent on 2026-09-22. Applicant: Samsung HME America, Inc., dba NeuroLogica Corp.. Device class: 2.
Summary
Two CT scanners are covered here: the BodyTom 64 (NL4100) and the OmniTom Elite (NL5000). Both are filed under JAK, computed tomography X-ray systems. The record doesn't describe either model beyond its name.
Class II, 21 CFR 892.1750. The Radiology panel reviewed it as a Traditional 510(k).
The applicant is Samsung HME America, Inc., doing business as NeuroLogica Corp., in Danvers, Massachusetts. Review took 169 days (April 6 to September 22, 2026).
Clearance details
- Applicant
- Samsung HME America, Inc., dba NeuroLogica Corp.
- Product code
- Product code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code JAK
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.