Catalog Number

-

Brand Name

PowerLook Tomo Detection (ProFound AI)

Version/Model Number

V2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 2019

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

K182373

Product Code

QDQ

Product Code Name

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Public Device Record Key

7b66ec62-b820-4371-b8cd-1844e52eddb8

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

December 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-