Catalog Number

8010267-01

Brand Name

D-SPECT VISTA

Version/Model Number

002

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

K161740

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Public Device Record Key

b3b591ca-51c4-43a5-98e0-976c014dc95b

Public Version Date

October 01, 2020

Public Version Number

2

DI Record Publish Date

June 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-