Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rayvolve LN

K-Number: K243831 · 2025-03-26

ApplicantAZmed
Decision Date2025-03-26
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rayvolve LN is a medical device manufactured by AZmed. It received FDA 510(k) clearance on 2025-03-26 under approval number K243831. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rayvolve LN?

Rayvolve LN is a medical device that received FDA 510(k) clearance on 2025-03-26. It is manufactured by AZmed. The 510(k) number is K243831.

When was Rayvolve LN approved by the FDA?

Rayvolve LN received FDA 510(k) clearance on 2025-03-26, under approval number K243831.

What company makes Rayvolve LN?

Rayvolve LN is manufactured by AZmed.

What is the FDA product code for Rayvolve LN?

The FDA product code for Rayvolve LN is MYN.

Other Devices by AZmed

K243808Rayvolve PTX-PE K260378Rayvolve

Related Devices (Code: MYN)

K201560Auto Lung Nodule DetectionSamsung Electronics Co., Ltd. K210666Chest-CADImagen Technologies, Inc. K220928Overjet Calculus AssistOverjet, Inc. K213353Aorta-CADImagen Technologies, Inc. K212519Overjet Caries AssistOverjet, Inc. K213795Videa Caries AssistVideahealth, Inc.

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.

↑