FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
Summary
Echosens received 510(k) clearance for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630), a IYO device. Cleared on 2023-03-02.
Details
Source
510(k) Clearance
External ID
K223902
Action Date
2023-03-02
Status
Traditional
Category
device
Product Code
IYO
Product Description
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630). Product code: IYO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Echosens has received 2 total clearances in our database.
Echosens has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Echosens have FDA actions?
Echosens has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223902" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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