QQO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cranial Measurement Software
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| SoftSpot (K212045) | Pediametrix, Inc. | 2021-09-28 |
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