FibroScan 630
by Echosens France 510(k)
510(k) K200655
Product code IYO
Overview
The FibroScan 630 is a non-invasive ultrasound-based device designed for transient elastography, specifically to measure liver stiffness and liver steatosis. It falls under the category of diagnostic imaging devices used to assess liver fibrosis and fatty infiltration in patients with suspected or confirmed chronic liver disease. By providing quantitative data on tissue stiffness, it aids clinicians in evaluating liver condition without the need for invasive procedures.
The device is supplied as a reusable medical instrument intended for clinical use in hospital or outpatient settings. It features a washable touch keyboard and a 19-inch touchscreen for enhanced usability, with an integrated M+ probe capable of adjusting frequency to 100 Hz for spleen examinations. Sterility is maintained through manufacturer-provided cleaning protocols, and its regulatory status includes FDA 510(k) clearance under the Radiology Advisory Committee. The device is classified under product code IYO and is manufactured by Echosens in Paris, France.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200655 | Date16 Jul 2020 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Echosens
Questions
What is the FibroScan® 630 used for?
The FibroScan® 630 is designed for transient elastography, a non-invasive ultrasound technique that measures liver stiffness and steatosis. This helps clinicians assess liver fibrosis and fatty infiltration in patients with chronic liver disease, eliminating the need for invasive biopsies. The device provides quantitative data to evaluate liver condition safely and efficiently.
How is the FibroScan® 630 supplied and intended for use?
The FibroScan® 630 is supplied as a reusable medical instrument intended for clinical use in hospitals or outpatient settings. Its design includes a washable touch keyboard and a 19-inch touchscreen for ease of operation. The device is engineered for durability and repeated use in diagnostic environments.
How is sterility maintained for the FibroScan® 630?
Sterility for the FibroScan® 630 is maintained through manufacturer-provided cleaning protocols. Since it is a reusable device, proper disinfection and maintenance procedures must be followed to ensure hygiene and prevent cross-contamination between patients. Always refer to the manufacturer’s guidelines for detailed cleaning instructions.
Does the FibroScan® 630 include specialized probes, and what are their capabilities?
Yes, the FibroScan® 630 comes with an integrated M+ probe that adjusts its frequency to 100 Hz for spleen examinations. This probe is optimized for transient elastography, allowing the device to assess liver stiffness and other tissue properties accurately. The adjustable frequency ensures compatibility with different anatomical assessments.
What regulatory approvals does the FibroScan® 630 hold, and how does it classify?
The FibroScan® 630 holds FDA 510(k) clearance under the Radiology Advisory Committee, classified as substantially equivalent. It is also categorized under product code IYO, indicating its classification as a diagnostic imaging device. The clearance reflects its compliance with U.S. regulatory standards for safety and effectiveness.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K200655