Identity
- Trade Name
- Adora DRFi FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- The Adora DRFi X-ray device is a ceiling suspended universal x-ray system using direct radiography and radioscopy on flat panels for diagnostic purpose. The system can be used for a wide range of x-ray examinations of the whole body, on both adult and pediatic patients. FDA UDI
- Model / Reference
- 04550010 FDA UDI
- Description
- The Adora DRFi X-ray device is a ceiling suspended universal x-ray system using direct radiography and radioscopy on flat panels for diagnostic purpose. The system can be used for a wide range of x-ray examinations of the whole body, on both adult and pediatic patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000862 FDA UDI
- 510(k) Number
- K242948 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Commercial Distribution
- 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
No
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 general-purpose fluoroscopic x-ray system, digital
Adora DRFi by Nrt - Nordisk Røntgen Teknik A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.
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Cleared under the same submission
K242948 also covers:
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Adora Accessory — Nrt - Nordisk Røntgen Teknik A/S
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nrt - Nordisk Røntgen Teknik A/S
Sources (1)
- FDA UDI 5ec25fef-969c-489c-8967-272e47500e0c 35 fields · synced May 30, 2026