QQO

Cranial Measurement Software

Product code

QQO

Device name

Cranial Measurement Software

Device class

Class 1

21 CFR

21 CFR 878.4800

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).