FDA.reportPublic FDA data

iQ-SYSTEM PACS

Primary DI
B403IQS120
Brand
iQ-SYSTEM PACS
Company
IMAGE Information Systems Europe GmbH
Model
1.2
Device description
iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K062488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062488000IQ-SYSTEM PACS SYSTEMImage Information Systems, Ltd.2006-09-19LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B403IQS120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system digital archive deviceA mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341050957
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B403IQS11004iQ-SYSTEM PACS1.102026-02-19
B403IQS150iQ-SYSTEM PACS1.52018-07-11
B403IQS190iQ-SYSTEM PACS1.92023-07-31
B403IQS170iQ-SYSTEM PACS1.72021-06-10
B403IQS160iQ-SYSTEM PACS1.62019-10-21
B403IQS130iQ-SYSTEM PACS1.32016-12-05
B403IQS140iQ-SYSTEM PACS1.42017-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
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
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