A1417MCW

Primary DI
08800070400036
Brand
A1417MCW
Company
H&abyz Co., Ltd
Model
A1417MCW
Device description
The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area.The device communicates by the wired Ethernet and wireless Wi-Fi communication feature.The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz).The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
Published
2023-04-07
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
K223930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223930000A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.2023-03-06MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800070400036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070400036088000704000368800070400036

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689514436
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800070400074HnX-P1HnX-P12025-08-12
08800070400166HnX-PBHnX-PB2025-08-12
08800070400005ADDHAD1417MCWHAD1417MCW2023-04-07
08800070400012HAD1717MCHAD1717MC2023-04-07
08800070400029A1717MCWA1717MCW2023-04-07
08800070400043F1417MCWF1417MCW2023-04-07
08800070400050ADDHAD1717MCWHAD1717MCW2023-04-07

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