X-ray beam limiting device

GUDID 04987670101670

CANON MEDICAL SYSTEMS CORPORATION

Automatic-aperture-control diagnostic x-ray system collimator
Primary Device ID04987670101670
NIH Device Record Key43aefa4a-bc33-40d0-b4f3-bc0d4edd6e6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray beam limiting device
Version Model NumberBLR-15AA
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

Customer Support Contacts

Phone+1-8004211968
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104987670101670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPWDevice, beam limiting, x-ray, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-11

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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