NovaMG

FDA UDI

Class II (US FDA UDI)

by Novarad Corporation

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 1.8.6 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: B109NOVAMG1860 FDA UDI
510(k) Number: K073272 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Radiological PACS software

NovaMG by Novarad Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

AVIEW — CORELINE SOFT CO., LTD. · Class II
ThinkingNet — THINKING SYSTEMS CORP. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II

Cleared under the same submission

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 f813ff19-a69b-4dc8-b2b1-e4489fe364e1 35 fields · synced Jun 6, 2026