K240890 is an FDA 510(k) clearance for the PanopticAI Vital Signs. This device is classified as a Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (Class II - Special Controls, product code QME).
Submitted by PanopticAI technologies Limited (Hong Kong, HK). The FDA issued a Cleared decision on December 23, 2024, 266 days after receiving the submission on April 1, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2785. The Device Uses Software Algorithms To Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device Is Not Intended To Independently Direct Therapy..
| 510(k) Number | K240890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2024 |
| Decision Date | December 23, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QME - Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2785 |
| Definition | The Device Uses Software Algorithms To Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device Is Not Intended To Independently Direct Therapy. |