RADspeed Pro

GUDID 04540217060269

SHIMADZU CORPORATION

Stationary basic diagnostic x-ray system, digital
Primary Device ID04540217060269
NIH Device Record Key828ef3a6-6ec4-4e1a-ac42-36d0f8fcb4b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRADspeed Pro
Version Model Number503-79460-64
Company DUNS690558747
Company NameSHIMADZU CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
GS104540217060269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-06
Device Publish Date2019-04-26

On-Brand Devices [RADspeed Pro]

04540217059959503-79460-52
04540217059942503-79460-51
04540217052493503-79460-43
04540217052486503-79460-42
04540217052479503-79460-41
04540217052424503-79460-26
04540217052417503-79460-23
04540217052400503-79460-22
04540217052394503-79460-21
04540217052387503-79460-06
04540217052370503-79460-03
04540217052363503-79460-02
04540217052356503-79460-01
04540217040315503-77550-11
04540217040308503-77550-10
04540217040292503-77550-09
04540217060269503-79460-64
04540217060252503-79460-63
04540217060245503-79460-62
04540217060238503-79460-61
04540217060221503-79460-53
04540217071395566-26000-65
04540217071388566-26000-64
04540217071371566-26000-63
04540217071364566-26000-62
04540217071357566-26000-61
04540217071340566-26000-60
04540217071333566-26000-54
04540217071326566-26000-53
04540217071319566-26000-50

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