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

FDA 510(k)

FibroScan® 630

K-Number: K200655 · 2020-07-16

ApplicantEchosens
Decision Date2020-07-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FibroScan® 630 is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K200655. 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® 630?

FibroScan® 630 is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Echosens. The 510(k) number is K200655.

When did FibroScan® 630 receive FDA 510(k) clearance?

FibroScan® 630 received FDA 510(k) clearance on 2020-07-16, under 510(k) number K200655.

Who is the listed applicant for FibroScan® 630?

The FDA 510(k) record lists Echosens as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FibroScan® 630?

The FDA product code for FibroScan® 630 is IYO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06519331Development of a New Method for Liver Stiffness Measurement Using FibroScanRECRUITINGNCT07400289Development of a FibroScan Liver Examination Using a Single ProbeRECRUITING

Other records listing Echosens as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)K212035FibroScan 230K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)K172142FibroScan 430 Mini+

View all 8 devices →

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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.

↑