Catalog Number

-

Brand Name

X-ray Flat Panel Detector

Version/Model Number

CareView 1500P

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

K162178

Product Code

MQB

Product Code Name

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Public Device Record Key

2e63c843-92ef-4b90-ba32-2b56eee0cd3c

Public Version Date

August 01, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-