FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
K Number: K202856
·
Decision Jan 25, 2021
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
92
Review Days
119
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Basic Information
- Device Name
- Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
- K Number
- K202856
- 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
- September 28, 2020
- Decision Date
- January 25, 2021
- 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
·Radiology
Other Clearances by Edan Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251591 | Holter ECG and ABP system (HolterABP) | Feb 9, 2026 | Substantially Equivalent |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Dec 23, 2025 | Substantially Equivalent |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Aug 27, 2025 | Substantially Equivalent |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Jul 29, 2025 | Substantially Equivalent |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Feb 20, 2025 | Substantially Equivalent |
| 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 |