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Avanse DR
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1800001Model Avanse DR
by Visaris
Identity
- Trade Name
- Avanse DR EUDAMEDVisaris Avanse FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements. FDA UDI
- Model / Reference
- Avanse DR EUDAMEDFDA UDI1800001 EUDAMED
- Description
- Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08606102809033 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08606102809033 EUDAMED
- 510(k) Number
- K150725 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11031192 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Czechia 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
No
FDA UDI
Avanse DR by Visaris — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08606102809033 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Visaris
- EUDAMED SRN
- RS-MF-000005209
- Authorised Representative
- VISARIS d.o.o. SI-AR-000022682
Sources (2)
- EUDAMED fbd2da60-597c-4896-a34b-46f0a64cd3ce 61 fields · synced Jun 19, 2026
- FDA UDI 4c04c237-a24e-4816-baaa-d727515b6a80 35 fields · synced May 30, 2026