PanopticAI Vital Signs (1.6.1-22)— 510(k) K260066
Substantially EquivalentPanopticAI Technologies Limited
FDA 510(k) clearance K260066 for PanopticAI Vital Signs (1.6.1-22), Substantially Equivalent on 2026-05-21. Applicant: PanopticAI Technologies Limited. Device class: 2.
Summary
PanopticAI Vital Signs (1.6.1-22) is from PanopticAI Technologies, filed under QME, software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
Class II, 21 CFR 870.2785. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).
PanopticAI filed from Hong Kong. Review took 132 calendar days (January 9 to May 21, 2026).
Clearance details
- Applicant
- PanopticAI Technologies Limited
- Product code
- Product code QME
- Device class
- Class 2
- Regulation
- 21 CFR 870.2785
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hong Kong, HK
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