Identity
- Trade Name
- NOVAPACS EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- NOVAPACS EUDAMEDA picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. FDA UDI
- Model / Reference
- NOVAPACS EUDAMED8.7.11 EUDAMEDNovaPACS 8.7.11 FDA UDI
- Description
- A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B109NOVAPACS87110 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B109NOVAPACS5H EUDAMED
- Direct Marketing DI
- B109NOVAPACS87110 EUDAMED
- 510(k) Number
- K171754 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Novapacs by Novarad Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171754 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160371 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B109NOVAPACS5H | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novarad Corporation
- EUDAMED SRN
- US-MF-000028327
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 61a27860-e4c6-41b2-add2-a5e200d07c4f 61 fields · synced Jul 9, 2026
- FDA UDI c539b9e1-124e-47b1-af60-c3f1fb2ee6a6 35 fields · synced May 30, 2026
- FDA 510(k) K171754 1 fields · synced May 18, 2026