Catalog Number

-

Brand Name

Optimized Positioning System (OPS) Plan

Version/Model Number

1250-1300

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"

Yes

For Single-Use

Yes

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

K171847

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

db34261a-97d3-4d87-85b0-ce55c4b63e80

Public Version Date

October 07, 2019

Public Version Number

2

DI Record Publish Date

April 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-