FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
K Number: K223902
·
Decision Mar 2, 2023
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
11
Review Days
64
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Basic Information
- Device Name
- FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
- K Number
- K223902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Echosens
- Date Received
- December 28, 2022
- Decision Date
- March 2, 2023
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Echosens
| K Number | Device Name | ||
|---|---|---|---|
| K212035 | FibroScan 230 | Jul 30, 2021 | Substantially Equivalent |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | Mar 25, 2021 | Substantially Equivalent |
| K200655 | FibroScan® 630 | Jul 16, 2020 | Substantially Equivalent |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Jul 9, 2018 | Substantially Equivalent |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Nov 14, 2017 | Substantially Equivalent |
| K172142 | FibroScan 430 Mini+ | Sep 13, 2017 | Substantially Equivalent |
| K160524 | FibroScan 530 Compact | Mar 18, 2016 | Substantially Equivalent |
| K150239 | FibroScan | Sep 1, 2015 | Substantially Equivalent |
| K150949 | FibroScan | Jun 3, 2015 | Substantially Equivalent |
| K123806 | FIBROSCAN | Apr 5, 2013 | Substantially Equivalent |