FibroScan— 510(k) K150949
Substantially EquivalentEchosens
FDA 510(k) clearance K150949 for FibroScan, Substantially Equivalent on 2015-06-03. Applicant: Echosens. Device class: 2.
Clearance details
- Applicant
- Echosens
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
Recent devices under product code IYO
view allMore clearances from Echosens
view all- K223902 — FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
- K212035 — FibroScan 230
- K203273 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
- K200655 — FibroScan® 630
- K181547 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.