FDA.reportPublic FDA data

NovaPACS

Primary DI
B109NOVAPACS9160
Brand
NovaPACS
Company
Novarad Corporation
Model
NovaPACS 9.1.6
Device description
A picture archiving and communication system software that retrieves, archive, distributes, and displays images and data from all common modalities.
Published
2026-05-21
Public version status
New
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
K171754000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B109NOVAPACS9160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS 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.

Contacts#

Phone, Email table
PhoneEmail
18776682723info@novarad.net

Regulatory Flags#

DUNS number
071991843
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B109NOVAPACS87110NovaPACSNovaPACS 8.7.112020-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
17540262140262Change Healthcare Stratus Imaging ViewerChange Healthcare Canada CompanyLLZ2026-04-16
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28