FDA.reportPublic FDA data

Box for ExamVue PACS(outside 265mmx185mmx150mm)

Primary DI
08809413810471
Brand
Box for ExamVue PACS(outside 265mmx185mmx150mm)
Company
JPI HEALTHCARE. CO., LTD.
Model
ExamVue PACS
Device description
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.
Published
2020-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809413810471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809413810471088094138104718809413810471

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
516 513-1330cust.serv@jpihealthcare.com

Regulatory Flags#

DUNS number
687797852
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809413811096ExamVue ApexEVA 10W2026-05-14
08809413811126ExamVue ApexEVA 14W2026-05-14
08809413811133ExamVue ApexEVA 17W2026-05-14
08809413810525Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:1)Grid-10002020-11-11
08809413810679ExamVue ExamVue Duo2023-06-15
08809413810532Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:2)Grid-10002020-11-11
08809413810549Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:3)Grid-10002020-11-11
08809413810556Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:4)Grid-10002020-11-11
08809413810563Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:5)Grid-10002020-11-11
08809413810570Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:6)Grid-10002020-11-11
08809413810587Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:7)Grid-10002020-11-11
08809413810594Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:8)Grid-10002020-11-11
08809413810600Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:9)Grid-10002020-11-11
08809413810617Box for radiographic Grid-1000(G5(outside620mmx140mmx590mm),packing quantity:10)Grid-10002020-11-11
08809413810495Box for radiographic Grid-1000(P-5(outside 1440mmx190mmx160mm))Grid-10002020-11-03
08809413810501Box for radiographic Grid-1000(P-10(outside 1440mmx340mmx590mm))Grid-10002020-11-03
08809413810518Box for radiographic Grid-1000(P-15 (outside 1440mmx890mmx590mm))Grid-10002020-11-03
08809413810488Box for ExamVue DR(outside 265mmx185mmx150mm)ExamVue DR2020-04-10
08809413810464Radiographic GridGrid-30002020-04-06
08809413810204Radiographic gridGrid-10002020-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
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