510(k) K241439

Device

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Applicant

Vuno, Inc.

510(k) number

K241439

Product code

QFM

Decision

Substantially Equivalent (SESE)

Decision date

2024-11-15

Date received

2024-05-21

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