PET-CT SCANNER

GUDID 04987670103810

This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.

CANON MEDICAL SYSTEMS CORPORATION

PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system PET/CT system
Primary Device ID04987670103810
NIH Device Record Keya4c6fff4-8314-4016-90d1-105b489a7cc3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePET-CT SCANNER
Version Model NumberPCD-1000A
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
GS104987670103810 [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 Date2021-12-22
Device Publish Date2021-12-14

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

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
04987670106033 - CONVEX ARRAY TRANSDUCER2024-04-22
04987670106057 - CONVEX ARRAY TRANSDUCER2024-04-22
04987670100680 - BIOPSY ADAPTOR2024-04-16
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