Catalog Number

-

Brand Name

ScanX Edge

Version/Model Number

G8300

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

K170733

Product Code

MUH

Product Code Name

System, X-Ray, Extraoral Source, Digital

Public Device Record Key

f552d9f1-0bd4-49d7-bc1f-74bf2e165235

Public Version Date

March 17, 2020

Public Version Number

1

DI Record Publish Date

March 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-