FDA product code QQO: Cranial Measurement Software
QQO is the FDA product code for cranial measurement software. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under QQO. The average 510(k) review took 90 days (median 90).
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.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Measurement Software |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | NE — Neurology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QQO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 90 |
Compare with all 510(k) review times · Search every QQO clearance
Top QQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pediametrix, Inc. | 1 | 2021-09-28 |
Most recent QQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212045 | Pediametrix, Inc. | SoftSpot | 2021-09-28 | 90 |
Recalls for QQO devices
openFDA lists no recalls for product code QQO.
Frequently asked questions
What is FDA product code QQO?
QQO is the FDA product code for cranial measurement software. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the Neurology panel.
What device class is QQO?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QQO?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most QQO clearances?
Pediametrix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQO
- Run a recall and safety report across every QQO manufacturer
- Watch product code QQO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times