FDA.reportPublic FDA data

NovaMG

Primary DI
B109NOVAMG1840
Brand
NovaMG
Company
Novarad Corporation
Model
NovaMG 1.8.4
Device 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.
Published
2017-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073272000WORKSTATIONONE BREAST IMAGING WORKSTATIONThree Palm Software, LLC2007-12-11LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B109NOVAMG1840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system application softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18776682723info@novarad.net

Regulatory Flags#

DUNS number
071991843
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B109NOVAPACS9160NovaPACSNovaPACS 9.1.62026-05-21
B109NOVAPACS9150NovaPACSNovaPACS 9.1.52025-12-17
B109VISAR30670VisARVisAR 3.0.672025-12-11
B109NOVAPACS9140NovaPACSNovaPACS 9.1.42025-08-20
B109VISAR2880VisARVisAR 2.882025-06-24
B109NOVAPACS9130NovaPACSNovaPACS 9.1.32025-05-26
B109VISAR2730VisARVisAR 2.732024-12-16
B109NOVAPACS81070NovaPACSNovaPACS 8.10.72024-03-11
B109VISAR2150VisARVisAR 2.1.52024-02-12
B109NOVAPACS81050NovaPACSNovaPACS 8.10.52024-02-09
B109NOVAPACS8780NovaPACSNovaPACS 8.7.82019-08-16
B109OPENSIGHT187060OpenSightOpenSight 1.87062019-08-16
B109NOVAPACS81030NovaPACSNovaPACS 8.10.32023-06-30
B109NOVAPACS8930NovaPACSNovaPACS 8.9.32022-09-23
B109NOVAPACS8920NovaPACSNovaPACS 8.9.22022-07-11
B109NOVAPACS8910NovaPACSNovaPACS 8.9.12022-04-18
B109NOVAPACS8850NovaPACSNovaPACS 8.8.52022-01-17
B109OPENSIGHT188040OpenSightOpenSight 1.88042021-07-09
B109NOVAPACS8840NovaPACSNovaPACS 8.8.42021-05-03
B109NOVAPACS8830NovaPACSNovaPACS 8.8.32021-01-25

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