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)

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

K-Number: K173034 · 2017-11-14

ApplicantEchosens
Decision Date2017-11-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is a medical device manufactured by Echosens. It received FDA 510(k) clearance on 2017-11-14 under approval number K173034. 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, and 430 Mini+)?

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is a medical device that received FDA 510(k) clearance on 2017-11-14. It is manufactured by Echosens. The 510(k) number is K173034.

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

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) received FDA 510(k) clearance on 2017-11-14, under approval number K173034.

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

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

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

The FDA product code for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) 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: 34161248 Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review. IEEE journal of biomedical and health informatics (2021) PMID: 33844189 New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions. Therapeutic innovation & regulatory science (2021)

Other Devices by Echosens

K160524FibroScan 530 Compact K172142FibroScan 430 Mini+ K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) K200655FibroScan® 630 K212035FibroScan 230 K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

View all 8 devices →

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.

↑