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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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 x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
687797852
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
08809413810143ExamVueExamVue DR2016-09-23
08809413810174ExamVueExamVue PACS2017-04-14
08809413810471Box for ExamVue PACS(outside 265mmx185mmx150mm)ExamVue PACS2020-04-10
08809413810488Box for ExamVue DR(outside 265mmx185mmx150mm)ExamVue DR2020-04-10
08800017000107DRE DuoJPI-DRED-DCN/012026-07-03
08800017000114DRE DuoJPI-DRED-ECN/012026-07-03
08800017000121DRE DuoJPI-DRED-BDN/012026-07-03
08800017000138DRE DuoJPI-DRED-BGN/012026-07-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000138DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08683161912041GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
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
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
00195278832252NAGE Hualun Medical Systems Co., LtdKPR2024-07-01
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00195278713759NAGE Hualun Medical Systems Co., LtdKPR2023-09-18
00195278713766NAGE Hualun Medical Systems Co., LtdKPR2023-09-18
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
04056869279985MULTIX ImpactSiemens Shanghai Medical Equipment Ltd.KPR2021-04-20
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