Nanox.ARC X
by Nano-X Imaging, Ltd. GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290018465011 | Date4 Sep 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Multi-directional tomography x-ray system
- Model / Reference
- Nanox.ARC X
- Primary DI / UDI-DI
- 07290018465011
- FDA Product Code
- IZF, MQB
- GMDN Term
- Multi-directional tomography x-ray system
- Device Class
- Class II
- Regulation Number
- 892.1740, 892.1680
- Commercial Distribution
- In Commercial Distribution
Other devices from Nano-X Imaging, Ltd.
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No