FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Nanox.ARC
K Number: K222934
·
Decision Apr 28, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
5
Review Days
214
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Basic Information
- Device Name
- Nanox.ARC
- K Number
- K222934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nano-X Imaging , Ltd.
- Date Received
- September 26, 2022
- Decision Date
- April 28, 2023
- Product Code
- IZF
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
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