FDA.reportPublic FDA data

Discovery

Primary DI
00840682136709
Brand
Discovery
Company
GE Hualun Medical Systems Co., Ltd
Model
XR656 HD Upgrade
Device description
XR656HD UDI Label
Published
2018-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172869000Discovery XR656 HDGe Hualun Medical Systems Co. , Ltd.2017-10-20KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682136709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682136709008406821367098406821367090840682136709

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging conversion systemAn assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554408665
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682146197RevolutionACT LMB2019-07-25
00840682116701FlashPad5340000-82016-08-01
00840682116732FlashPad5340000-72016-08-01
00198953056103DefiniumPace Select ETB4600UDI2026-02-12
00198953056158DefiniumTempo SelectB4400UDI2026-02-12
00840682145541OECOne CFD2019-08-09
00198953054949NAGCTS-C112025-09-30
00195278913814DefiniumTempo SelectB2400UDI2025-09-05
00840682121071Flashpad HD43432019-06-27
00195278901880NAGCTS-C12025-06-09
00195278840226DiscoveryXR656 HD Upgrade2024-07-04
00195278840233OptimaXR646 HD Upgrade2024-07-04
00840682142168OptimaXR646 HD Upgrade2018-11-14
00195278832252NAVMWS-22024-07-01
00195278713759NAVMWS-1VMWS-12023-09-18
00195278713766NAVFTBL-1VFTBL-12023-09-18
00840682145503D630 UpgradeH2401XFH2401XF2021-04-30
00840682120777ProteusXRa2016-08-01
00840682138925NAB2100BLT2018-11-13
00840682138932NA57948072018-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
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
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340277Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
08056600520051Nical Flat PanelNICAL SPAMQB2023-10-09
08057737122217Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29
08057737122262Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29