K212045 is an FDA 510(k) clearance for the SoftSpot. This device is classified as a Cranial Measurement Software (Class I - General Controls, product code QQO).
Submitted by Pediametrix, Inc. (Rockville, US). The FDA issued a Cleared decision on September 28, 2021, 90 days after receiving the submission on June 30, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 878.4800. 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) Number | K212045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2021 |
| Decision Date | September 28, 2021 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QQO - Cranial Measurement Software |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |
| 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. |