910SGA

GUDID 08800018600313

910SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor.

Rayence Co., Ltd.

Indirect flat panel x-ray detector
Primary Device ID08800018600313
NIH Device Record Key51324fac-7884-40a6-891d-3a540a324cca
Commercial Distribution StatusIn Commercial Distribution
Brand Name910SGA
Version Model Number910SGA
Company DUNS557804458
Company NameRayence Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108800018600313 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2016-09-16

Devices Manufactured by Rayence Co., Ltd.

08800018602218 - 1717WCE2024-09-27 Solid state x-ray imager (flat panel/digital imager)
08800018602225 - 1717WCE-HR2024-09-27 Solid state x-ray imager(flat panel/digital imager)
08800018602232 - 1717WCE-HS2024-09-27 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
08800018602249 - 1717WCE-GF2024-09-27 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
08800018602195 - 0909FCC2024-03-29 X-ray, Fluoroscopic, image-intensified system
08800018602201 - 0909FCC-HS2024-03-29 X-ray, Fluoroscopic, image-intensified system
08800018602140 - 1417WCE2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
08800018602157 - 1417WCE-HR2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.

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