QQO — Cranial Measurement Software Class I
FDA product code QQO covers "Cranial Measurement Software", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QQO
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- NE
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212045 | pediametrix | SoftSpot | September 28, 2021 |