CT SCANNER - CANON MEDICAL SYSTEMS CORPORATION

Duns Number:690575113

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More Product Details

Catalog Number

-

Brand Name

CT SCANNER

Version/Model Number

TSX-306A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192188

Product Code Details

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Device Record Status

Public Device Record Key

3440e0f4-f35d-4bb8-a908-bf60068e5a92

Public Version Date

November 09, 2021

Public Version Number

1

DI Record Publish Date

November 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CANON MEDICAL SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 200