RAYSCAN a+

GUDID 08800003001354

Ray Co., Ltd

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Primary Device ID08800003001354
NIH Device Record Key7d0ad5e6-5fb0-43e9-a7b9-3f46b053381c
Commercial Distribution Discontinuation2023-02-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRAYSCAN a+
Version Model NumberCT,Pano(FXDD-0606CA) + One shot Ceph(FXRD-1717VA)
Company DUNS690324087
Company NameRay 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800003001354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-22
Device Publish Date2023-02-14

Devices Manufactured by Ray Co., Ltd

08800003000241 - RAYSCAN α-Expert2024-05-06
08800003000258 - RAYSCAN α-Expert2024-05-06
08800003000265 - RAYSCAN α-Expert2024-05-06
08800003000272 - RAYSCAN α-Expert2024-05-06
08800003000289 - RAYSCAN α-Expert2024-05-06
08800003000296 - RAYSCAN α-Expert2024-05-06
08800003000302 - RAYSCAN α-Expert2024-05-06
08800003000319 - RAYSCAN α-Expert2024-05-06

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