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FDA 510(k)

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

K-Number: K223902 · 2023-03-02

ApplicantEchosens
Decision Date2023-03-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2023-03-02 under approval number K223902. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)?

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Echosens. The 510(k) number is K223902.

When was FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) approved by the FDA?

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) received FDA 510(k) clearance on 2023-03-02, under approval number K223902.

What company makes FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)?

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is manufactured by Echosens.

What is the FDA product code for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)?

The FDA product code for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is IYO.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41858417 AI-Driven Medical Device Risk Management: A New Paradigm Integrating Large Language Models and Prompt Engineering for Standard-Risk Knowledge Graph Construction and Application. Risk management and healthcare policy (2026) PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026)

Other Devices by Echosens

K160524FibroScan 530 Compact K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) K172142FibroScan 430 Mini+ K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) K200655FibroScan® 630 K212035FibroScan 230

View all 8 devices →

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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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