Catalog Number

001771

Brand Name

HeartSee Cardiac PET Processing Software

Version/Model Number

1.00

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

K181343

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Public Device Record Key

aceeea7d-615d-41c2-b12f-889ebf09f3bb

Public Version Date

August 06, 2019

Public Version Number

1

DI Record Publish Date

July 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-