Catalog Number

-

Brand Name

P-61

Version/Model Number

A9YC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K162504,K171716

Product Code

MQB

Product Code Name

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

Public Device Record Key

fd5bab9a-591d-4940-8a42-6cbde4e12b2b

Public Version Date

May 13, 2020

Public Version Number

6

DI Record Publish Date

January 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-