510(k) K221868

Device

QOCA image Smart CXR Image Processing System

Applicant

Quanta Computer, Inc.

510(k) number

K221868

Product code

QFM

Decision

Substantially Equivalent (SESE)

Decision date

2023-01-27

Date received

2022-06-27

Regulation

892.2080

Classification name

Radiological Computer-Assisted Prioritization Software For Lesions

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No