FDA.reportPublic FDA data

DRE Duo

Primary DI
08800017000138
Brand
DRE Duo
Company
JPI HEALTHCARE. CO., LTD.
Model
JPI-DRED-BGN/01
Published
2026-07-03
Public version status
New
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
K260482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260482000DRE DuoJpi Healthcare Co, Ltd.2026-06-15KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017000138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017000138088000170001388800017000138

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

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
true
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
08809413810679ExamVueExamVue Duo2023-06-15
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
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
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
08809413810679ExamVueJPI HEALTHCARE. CO., LTD.KPR2023-06-15
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