FDA.reportPublic FDA data

NovaPACS

Primary DI
B109NOVAPACS8680
Brand
NovaPACS
Company
Novarad Corporation
Model
NovaPACS 8.6.8
Device description
A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities.
Published
2018-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K171754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171754000NovaPACSNovarad Corporation2017-07-28LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B109NOVAPACS8680PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
18776682723info@novarad.net

Regulatory Flags#

DUNS number
071991843
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B109NOVAPACS81050NovaPACSNovaPACS 8.10.52024-02-09
B109NOVAPACS9160NovaPACSNovaPACS 9.1.62026-05-21
B109NOVAPACS9150NovaPACSNovaPACS 9.1.52025-12-17
B109NOVAPACS9140NovaPACSNovaPACS 9.1.42025-08-20
B109NOVAPACS9130NovaPACSNovaPACS 9.1.32025-05-26
B109NOVAPACS81070NovaPACSNovaPACS 8.10.72024-03-11
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
B109NOVAPACS87110NovaPACSNovaPACS 8.7.112020-02-10
B109NOVAPACS8770NovaPACSNovaPACS 8.7.72019-07-12
B109OPENSIGHT180760OpenSightOpenSight 1.80762019-07-12
B109NOVAPACS8760NovaPACSNovaPACS 8.7.62019-06-17

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