Identity
- Trade Name
- iRay SmartV FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Device Name
- Canis014D04V portable X-ray system (SmartV) FDA UDI
- Model / Reference
- Canis014D07V FDA UDI
- Description
- Canis014D04V portable X-ray system (SmartV) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975501940268 FDA UDI
- 510(k) Number
- K223010 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Hand-held intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iRay SmartV by Iray Imaging Technology (Haining) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K223010 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Iray Imaging Technology (Haining) Limited
Sources (1)
- FDA UDI 21a4cf96-a540-4e0b-83d0-4597f3d937d1 35 fields · synced Jun 8, 2026