FibroScan
FDA 510(k) K150949 · Echosens
510(k) numberK150949
Submission
- Device name
- FibroScan
- Applicant
- Echosens
Paris, FR - Received
- April 8, 2015
- Decision date
- June 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)IYO · Traditional | 03/02/2023SE |
| K212035 | FibroScan 230IYO · Special | 07/30/2021SE |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)IYO · Traditional | 03/25/2021SE |
| K200655 | FibroScan® 630IYO · Traditional | 07/16/2020SE |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)IYO · Special | 07/09/2018SE |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)IYO · Traditional | 11/14/2017SE |
| K172142 | FibroScan 430 Mini+IYO · Traditional | 09/13/2017SE |
| K160524 | FibroScan 530 CompactIYO · Special | 03/18/2016SE |
| K150239 | FibroScanIYO · Traditional | 09/01/2015SE |
| K123806 | FibroscanIYO · Traditional | 04/05/2013SE |
Questions and answers
When was FibroScan cleared by the FDA?
FibroScan (K150949) received a 510(k) decision of Substantially Equivalent on June 3, 2015, 56 days after the submission was received.
What is the product code of K150949?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.