# BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261125 |
| Device | BodyTom 64 (NL4100); OmniTom Elite (NL5000) |
| Applicant | Samsung HME America, Inc., dba NeuroLogica Corp. |
| Specialty / panel | Radiology |
| Product code | JAK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-06 |
| Decision date | 2026-09-22 |
| Review time (days) | 169 |
| Third-party review | No |
| Applicant location | Danvers, MA, US |

## Why this score
- 169-day review, longer than typical.
- Posted 44 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261125). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.