QQO · Class I · 21 CFR 878.4800

FDA Product Code QQO: Cranial Measurement Software

Cranial Measurement Software Is Intended To Be Used To Calculate And Display Physical Measurements Of The Head For Interpretation By A Qualified User In Conjunction With Other Clinical Methods.

Leading manufacturers include Pediametrix, Inc..

1
Total
1
Cleared
90d
Avg days
2021
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Cranial Measurement Software Devices (Product Code QQO)

1 devices
1–1 of 1

About Product Code QQO - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QQO since 2021, with 1 receiving FDA clearance (average review time: 90 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QQO devices are reviewed by the Neurology panel. Browse all Neurology devices →