K260066
- 510(k) number
- K260066
- Device name
- PanopticAI Vital Signs (1.6.1-22)
- Applicant
- PanopticAI Technologies Limited HK
- Product code
- QME — Software For Optical Camera-Based Measurement Of Pul
- Decision date
- 2026-05-21
- Date received
- 2026-01-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260066.pdf
Official FDA record: K260066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.