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FDA 510(k)

PanopticAI Vital Signs

K-Number: K240890 · 2024-12-23

ApplicantPanopticAI technologies Limited
Decision Date2024-12-23
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PanopticAI Vital Signs is a medical device manufactured by PanopticAI technologies Limited. It received FDA 510(k) clearance on 2024-12-23 under approval number K240890. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PanopticAI Vital Signs?

PanopticAI Vital Signs is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by PanopticAI technologies Limited. The 510(k) number is K240890.

When was PanopticAI Vital Signs approved by the FDA?

PanopticAI Vital Signs received FDA 510(k) clearance on 2024-12-23, under approval number K240890.

What company makes PanopticAI Vital Signs?

PanopticAI Vital Signs is manufactured by PanopticAI technologies Limited.

What is the FDA product code for PanopticAI Vital Signs?

The FDA product code for PanopticAI Vital Signs is QME.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Related Devices (Code: QME)

K211906Vital SignsOxehealth Limited DEN200019Oxehealth Vital SignsOxehealth Limited K220899Oxehealth Vital SignsOxehealth Limited K223622FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. K241633Informed Vital Core Application (IVC App)Mindset Medical, Inc. K232804FibriCheckQompium NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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