FDA.reportPublic FDA data

X-ray Flat Panel Detectors

Primary DI
06970597830172
Brand
X-ray Flat Panel Detectors
Company
CareRay Digital Medical Technology Co., Ltd.
Model
CareView 1500Cwe
Published
2020-08-14
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
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201932000X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.2020-08-07MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970597830172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970597830172069705978301726970597830172

GMDN Terms#

Term, Definition table
TermDefinition
Portable basic diagnostic x-ray system, digitalAn assembly of devices that comprise a general-purpose portable 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 portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and easily reassembled for use. It 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
06970597832022X-ray Flat Panel DetectorYosemiteView 4343W2023-09-04
06970597830752X-ray Flat Panel DetectorEverestView 4343X2023-02-01
06970597830271X-ray Flat Panel DetectorCareView 1800RF2022-08-27
06970597830479X-ray Flat Panel DetectorCareView 3600RF2021-03-01
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

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Primary DI, Brand, Company table
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08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
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08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
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