Aquilion Serve SP

GUDID 04987670106095

CANON MEDICAL SYSTEMS CORPORATION

Full-body CT system
Primary Device ID04987670106095
NIH Device Record Key7a7de9f9-e2fe-44eb-a1a8-468d5097eead
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquilion Serve SP
Version Model NumberTSX-307B
Company DUNS690575113
Company NameCANON MEDICAL SYSTEMS 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 Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS104987670106095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-12
Device Publish Date2024-07-04

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670104558 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670106095 - Aquilion Serve SP2024-07-12
04987670106095 - Aquilion Serve SP2024-07-12
04987670100925 - BIOPSY ADAPTOR2024-04-22
04987670104626 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104633 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104640 - ENDOCAVITARY TRANSDUCER2024-04-22
04987670104664 - CONVEX ARRAY TRANSDUCER2024-04-22

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