FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K Number: K251268
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
92
Review Days
243
Basic Information
- Device Name
- Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K Number
- K251268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edan Instruments, Inc.
- Date Received
- April 24, 2025
- Decision Date
- December 23, 2025
- Product Code
- IYN
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Edan Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K240320 | Patient Monitor (RespArray) | Jun 28, 2024 | Substantially Equivalent |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | May 16, 2024 | Substantially Equivalent |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Apr 19, 2024 | Substantially Equivalent |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Mar 8, 2024 | Substantially Equivalent |
| K232694 | Central Monitoring System (MFM-CMS) | Feb 5, 2024 | Substantially Equivalent |
| K230184 | Holter ECG and ABP System | Sep 25, 2023 | Substantially Equivalent |