AccessGUDID - DEVICE: NovaMG (B109NOVAMG1860)

GUDID

Device Identifier (DI) Information

Brand Name: NovaMG
Version or Model: NovaMG 1.8.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Novarad Corporation

Primary DI Number: B109NOVAMG1860
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071991843 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41670	Radiological PACS software	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073272	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f813ff19-a69b-4dc8-b2b1-e4489fe364e1
Public Version Date: February 08, 2024
Public Version Number: 6
DI Record Publish Date: May 22, 2018