DeviceClearance

Product code QQO— General, Plastic Surgery

SoftSpot

Classification name
Cranial Measurement Software
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QQO under 21 CFR 878.4800, via openFDA

Market context for product code QQO

FDA has cleared 1 device under product code QQO, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QQO

Recent clearances under product code QQO

Data sourced from openFDA. This site is unofficial and independent of the FDA.