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FDA 510(k)

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

K-Number: K203273 · 2021-03-25

ApplicantEchosens
Decision Date2021-03-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2021-03-25 under approval number K203273. 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® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)?

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Echosens. The 510(k) number is K203273.

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

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) received FDA 510(k) clearance on 2021-03-25, under approval number K203273.

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

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

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

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

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT04829175 Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry RECRUITING NCT07566728 ADAI - Home Care in Intelligent Environments Clinical Care Ecosystem for the Management of Home Digital Therapies Through the Use of Assistive Robots and Clinical Predictive Systems Based on Artificial Intelligence Systems COMPLETED NCT06877026 FibroScan-Reproducibility and Repeatability Study COMPLETED NCT04150120 eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness COMPLETED

Related PubMed Literature

PMID: 40978510 Federated learning: a privacy-preserving approach to data-centric regulatory cooperation. Frontiers in drug safety and regulation (2025)

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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