Catalog Number

9PMS3131

Brand Name

BodyMD

Version/Model Number

QuantumCam Gamma Camera System

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

K140206

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Public Device Record Key

44abf502-269c-43a1-b90c-e0aedb2e283f

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-