Catalog Number

-

Brand Name

NanoZoomer S360MD Slide scanner system

Version/Model Number

C13220-01MD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K213883

Product Code

PSY

Product Code Name

Whole Slide Imaging System

Public Device Record Key

01d9c2d3-5dd3-4461-a5a5-3cde4fcfe989

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-