510(k) K230074

Device

Rapid Aneurysm Triage and Notification

Applicant

Ischemaview, Inc.

510(k) number

K230074

Product code

QFM

Decision

Substantially Equivalent (SESE)

Decision date

2023-07-27

Date received

2023-01-10

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