Devices · Quantitative Insights, Inc

QuantX

Quantitative Insights, Inc is listed for QuantX (DEN170022). The FDA list gives July 19, 2017 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code POK as “Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer”: Assist users in characterizing lesions identified on acquired medical images openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170022

Official FDA database record

Date of final decision

July 19, 2017

Company on the FDA list

Quantitative Insights, Inc

Lead panel

Radiology

Primary product code

POK

openFDA device name for the code

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Device class

2

Regulation number

892.2060

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned