Catalog Number

SE 1301-0002

Brand Name

declipse®SPECT

Version/Model Number

declipseSPECT Viewer

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K123917

Product Code

IZD

Product Code Name

Probe, Uptake, Nuclear

Public Device Record Key

823cf8c0-460a-464e-86a9-f71f32cae389

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-