0909FCB

Primary DI
08800018600900
Brand
0909FCB
Company
Rayence Co., Ltd.
Model
0909FCB
Device description
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
Published
2021-10-29
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
K212753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2127530000909FCB, 1212FCARayence Co., Ltd.2021-10-18MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018600900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018600900088000186009008800018600900

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 Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557804458
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088000186022562430TCA2430TCA2025-04-08
088000186022181717WCE1717WCE2024-09-19
088000186022251717WCE-HR1717WCE-HR2024-09-19
088000186022321717WCE-HS1717WCE-HS2024-09-19
088000186022491717WCE-GF1717WCE-GF2024-09-19
088000186021950909FCC0909FCC2024-03-21
088000186022010909FCC-HS0909FCC-HS2024-03-21
088000186021401417WCE1417WCE2023-06-29
088000186021571417WCE-HR1417WCE-HR2023-06-29
088000186021641417WCE-HS1417WCE-HS2023-06-29
088000186021711417WCE-GF1417WCE-GF2023-06-29
08800018600924Vatech Clismile11-12112022-05-31
08800018600931Vatech Clismile 11-12212022-05-31
08800018600948Vatech Clismile 11-12122022-05-31
08800018600955Vatech Clismile 11-12222022-05-31
08800018600962Vatech Clismile 11-12132022-05-31
08800018600979Vatech Clismile 11-12232022-05-31
08800018600986Vatech Clismile 11-12142022-05-31
08800018600993Vatech Clismile 11-12152022-05-31
08800018601006Vatech Clismile 11-12242022-05-31

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