Catalog Number

-

Brand Name

syngo.CT Coronary Analysis

Version/Model Number

11060622

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100637

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

a77ea881-d8e2-4085-988c-e2f43bceebc6

Public Version Date

November 17, 2021

Public Version Number

5

DI Record Publish Date

March 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-