Identity
- Trade Name
- NovaMG™ FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- NovaPACS™ is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS™ contains WorkstationOne™ software developed by Three Palm Software and branded as NovaMG™ with WorkstationOne™ for softcopy reading and interpretation of digital mammography images by Radiologists. FDA UDI
- Model / Reference
- NovaMG 1.8.2 FDA UDI
- Description
- NovaPACS™ is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS™ contains WorkstationOne™ software developed by Three Palm Software and branded as NovaMG™ with WorkstationOne™ for softcopy reading and interpretation of digital mammography images by Radiologists. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B109NOVAMG1820 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
NovaMG™ by Novarad Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novarad Corporation
Sources (1)
- FDA UDI d0dfc4c7-6c0d-4ba5-8ea7-c782c5dc87de 34 fields · synced May 30, 2026