FDA.reportPublic FDA data

ExamVue

Primary DI
08809413810679
Brand
ExamVue
Company
JPI HEALTHCARE. CO., LTD.
Model
ExamVue Duo
Device description
ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for digital radiography and use by radiologists and radiology technicians. ExamVue Duo saves the digital X-ray images acquired from the detector and process it to make the better image quality. The software also manages patient information, capture, and store diagnostic images in an internal database. It also supports DICOM 3.0 protocol which allows compatibility with the network programs such as the PACS system.
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213057000ExamVue DuoJpi Healthcare Co, Ltd.2022-02-18KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809413810679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809413810679088094138106798809413810679

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

Regulatory Flags#

DUNS number
687797852
Device count
1
Serial number
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
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
08809413810471Box for ExamVue PACS(outside 265mmx185mmx150mm)ExamVue PACS2020-04-10
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
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
04056869297309MOBILETT ImpactSiemens Healthcare GmbHKPR2025-11-20
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
04540217071319RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071326RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071333RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071340RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
04056869262147MULTIX Impact CSiemens Shanghai Medical Equipment Ltd.KPR2021-03-22
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
00810030350002uDRUIH TECHNOLOGIES LLCKPR2020-04-29
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20