Identity
- Trade Name
- SKANRAD 400 FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- SKANRAD 400 - High Frequency Diagnostic X-ray system EUDAMEDSkanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation FDA UDI
- Model / Reference
- 303-000783-4 EUDAMEDFDA UDI
- Description
- Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904269409531 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08904269409531 EUDAMED
- 510(k) Number
- K220518 FDA UDI
- FDA Product Code
- KPR FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Stationary basic diagnostic x-ray system, digital
Skanrad 400 by Skanray Technologies — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Skanray Technologies
Sources (2)
- FDA UDI 3b2edb02-0c38-4b39-a52f-c87b1efcb310 34 fields · synced Aug 4, 2026
- EUDAMED 39ff3ae4-1dae-4955-97ba-45c8369546a4 61 fields · synced Aug 4, 2026