510(k) K261125
K261125 is an FDA 510(k) premarket notification submitted by Samsung HME America, Inc., Dba NeuroLogica Corp. for the device "BodyTom 64 (NL4100); OmniTom Elite (NL5000)". The FDA issued a decision of Substantially Equivalent on Sep 22, 2026. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 22, 2026
- Date Received
- Apr 6, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)