Identity
- Trade Name
- Advanced Visualization Workspace EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Advanced Visualization Workspace EUDAMEDAdvanced Visualization Workspace is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications. FDA UDI
- Model / Reference
- 881120 EUDAMEDAdvanced Visualization Workspace - 15 FDA UDI
- Description
- Advanced Visualization Workspace is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications. FDA UDI
Identifiers
- Catalog Number
- 881120 FDA UDI
- Primary DI / UDI-DI
- 00884838121553 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1052LU EUDAMED
- Direct Marketing DI
- 00884838121553 EUDAMED
- 510(k) Number
- K162025 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Advanced Visualization Workspace by Philips Medical Systems Nederland B.V. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM1052LU | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED a869ffb1-d18a-47c7-bcd5-174142bb75e3 61 fields · synced Oct 6, 2026
- FDA UDI d0d6f1a0-3eaf-4c7e-ae3b-584a7c213359 36 fields · synced May 30, 2026