510(k) K252649
K252649 is an FDA 510(k) premarket notification submitted by Nano-X Imaging , Ltd. for the device "TAP2D". The FDA issued a decision of Substantially Equivalent on February 2, 2026. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Nano-X Imaging , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2026
- Date Received
- August 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomographic
- Device Class
- Class II
- Regulation Number
- 892.1740
- Review Panel
- RA
- Submission Type