Catalog Number

-

Brand Name

Critical Care Suite

Version/Model Number

PACS 1.0

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

K183182

Product Code

QFM

Product Code Name

Radiological computer-assisted prioritization software for lesions

Public Device Record Key

eff01e43-80b9-4405-8e8b-8efd7e592196

Public Version Date

October 27, 2022

Public Version Number

3

DI Record Publish Date

November 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-