FDA.reportPublic FDA data

X-ray Flat Panel Detector

Primary DI
06970597832022
Brand
X-ray Flat Panel Detector
Company
CareRay Digital Medical Technology Co., Ltd.
Model
YosemiteView 4343W
Published
2023-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232058000YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.2023-08-03MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970597832022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970597832022069705978320226970597832022

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421333508
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970597831049X-ray Flat Panel DetectorYosemiteView 3643W2023-09-04
06970597830752X-ray Flat Panel DetectorEverestView 4343X2023-02-01
06970597830271X-ray Flat Panel DetectorCareView 1800RF2022-08-27
06970597830479X-ray Flat Panel DetectorCareView 3600RF2021-03-01
06970597830172X-ray Flat Panel DetectorsCareView 1500Cwe2020-08-14
06970597830745X-ray Flat Panel DetectorCareView 1800Cwe2020-08-14
06970597830721X-ray Flat Panel DetectorCareView 1800Le2019-12-16
06970597830035X-ray Flat Panel DetectorCareView 1500P2016-09-15
06970597830066X-ray Flat Panel DetectorCareView 1500C2016-09-15
06970597830073X-ray Flat Panel DetectorCareView 1500L2016-09-15
06970597830097X-ray Flat Panel DetectorCareView 1500Cw2016-09-15
06970597830219X-ray Flat Panel DetectorCareView 1800R2016-09-15
06970597830240X-ray Flat Panel DetectorCareView 1800L2016-09-15
06970597830257X-ray Flat Panel DetectorCareView 1800Cw2017-10-24
06970597830349X-ray Flat Panel DetectorCareView 750C2016-12-13
06970597830363X-ray Flat Panel DetectorCareView 750Cw2016-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
00190376601182IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
00195278840233OptimaGE Hualun Medical Systems Co., LtdMQB2024-07-04
00195278832252NAGE Hualun Medical Systems Co., LtdMQB2024-07-01
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26