Identity
- Trade Name
- Roentgen Works FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Roentgen Works 4.0.0 FDA UDI
- Model / Reference
- 4.0.0 FDA UDI
- Description
- Roentgen Works 4.0.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850631008223 FDA UDI
- FDA Product Code
- LMB FDA UDILLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2010 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Radiological PACS softwareRadiology DICOM image processing application softwareRadiology information system application software
Roentgen Works is a high-performance radiology information system designed to optimize patient care and streamline clinical workflows. Built with cutting-edge technology, this device streamlines digital imaging management, facilitates image analysis, and ensures compliance with regulatory requirements.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brit Systems
Sources (1)
- FDA UDI 1c1cb579-ecb7-4a7f-96a6-3b94651f0443 33 fields · synced Jul 11, 2026