Cleared Traditional

PanopticAI Vital Signs

K240890 · PanopticAI technologies Limited · Cardiovascular

Dec 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K240890 is an FDA 510(k) clearance for the PanopticAI Vital Signs, 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 review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K240890 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.