Catalog Number

-

Brand Name

syngo.SPECT Processing

Version/Model Number

11431531

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191309

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

30be2671-4e48-4db7-94bf-da06414e59f1

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

August 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-