Cranial Measurement Software
The Cranial Measurement Software is a Class 1 general controls device intended to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods, used in the assessment of cranial shape conditions such as plagiocephaly. It is subject to general controls under regulation 878.4800 in the General and Plastic Surgery specialty (reviewed by the Neurology panel). Product code QQO. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QQO
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212045 | SoftSpot | Sep 28, 2021 | Substantially Equivalent | Pediametrix, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.