1417PCA

GUDID 08800018600276

1417PCA is a digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images.

Rayence Co., Ltd.

Indirect flat panel x-ray detector
Primary Device ID08800018600276
NIH Device Record Key375f720c-7eb1-4204-a131-ae714a54cede
Commercial Distribution StatusIn Commercial Distribution
Brand Name1417PCA
Version Model Number1417PCA
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
GS108800018600276 [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.

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.
08800018602164 - 1417WCE-HS2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
08800018602171 - 1417WCE-GF2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
08800018600924 - Vatech Clismile2022-06-08 This product is a orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocc
08800018600931 - Vatech Clismile 2022-06-08 This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat maloc
08800018600948 - Vatech Clismile 2022-06-08 This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat maloc
08800018600955 - Vatech Clismile 2022-06-08 This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat maloc

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