Catalog Number

-

Brand Name

Panoramic Corporation

Version/Model Number

CCD Encompass

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

K141130

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Public Device Record Key

fb1c40bc-4924-40d1-8360-1b24d9dc68ba

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

May 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-