← Back to catalogue
Velocity Medical Imaging Data Comparison Software
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Velocity 4.1
Identity
- Trade Name
- Velocity Medical Imaging Data Comparison Software EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Velocity EUDAMED
- Model / Reference
- Velocity 4.1 EUDAMED4.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854393006022 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00854393006022 EUDAMED
- 510(k) Number
- K173636 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Velocity Medical Imaging Data Comparison Software by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173636 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00854393006022 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED ffb9cf96-3dea-4e33-9810-49b485e6fe0c 61 fields · synced Jul 15, 2026
- FDA UDI 9c7a9f81-b763-448d-a719-bb8200dad99b 33 fields · synced May 29, 2026
- FDA 510(k) K173636 1 fields · synced May 18, 2026