Catalog Number

-

Brand Name

X-CEL X-RAY CORPORATION

Version/Model Number

HF 718BD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160857

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Public Device Record Key

677eb1ef-3ac5-4109-a972-2762031e75f5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-