FDA UDI
In Commercial Distribution
🇺🇸 United States
Nanox.ARC
DI: 07290018465004
·
Model: 2.2.
·
NANO-X IMAGING LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nanox.ARC
- Primary DI
- 07290018465004
- Version / Model
- 2.2.
- Company Name
- NANO-X IMAGING LTD
- Labeler DUNS
- 521092973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 2
- Public Version Date
- 2024-02-26
- Public Version Status
- Update
- Public Device Record Key
- 6b971f96-3f80-435e-a426-70032ac596ab
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZF | System, X-Ray, Tomographic | Radiology | 892.1740 | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37660 | Multi-directional tomography x-ray system | An assembly of devices used to produce 2-dimensional cross-sectional (tomographic) images on x-ray film at a fixed angle and depth in relation to body position by coordinating a prescribed pattern of non-linear x-ray tube motion (elliptical, circular, clover shaped, spiral, as well as linear, depending on the system design) during exposure sequences. This approach causes the shadow of the selected plane to remain stationary on the moving film while the shadows in both directions of the plane have a relative displacement on the film and are either obliterated or blurred. This GMDN code reflects old technology, now superseded by computed tomography (CT) systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018465004 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222934 | 000 |