BodyTom Elite (NL4000)— 510(k) K253450
Substantially EquivalentNeuroLogica Corp., a Samsung Company
FDA 510(k) clearance K253450 for BodyTom Elite (NL4000), Substantially Equivalent on 2026-07-28. Applicant: NeuroLogica Corp., a Samsung Company. Device class: 2.
Summary
BodyTom Elite (NL4000) from NeuroLogica, a Samsung company, is filed under JAK, computed tomography X-ray systems. The record gives the model as NL4000 but no specs.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
NeuroLogica filed from Danvers, Massachusetts. Review took 299 calendar days (October 2, 2025 to July 28, 2026).
Clearance details
- Applicant
- NeuroLogica Corp., a Samsung Company
- 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.