FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)
K Number: K252498
·
Decision Dec 5, 2025
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
25
Review Days
119
Basic Information
- Device Name
- Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)
- K Number
- K252498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonoscape Medical Corp.
- Date Received
- August 8, 2025
- Decision Date
- December 5, 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)
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Other Clearances by Sonoscape Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | May 15, 2026 | Substantially Equivalent |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series) | Jan 17, 2025 | Substantially Equivalent |
| K231813 | Ultrasonic Gastrovideoscope | Mar 8, 2024 | Substantially Equivalent |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Feb 10, 2023 | Substantially Equivalent |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | Sep 15, 2022 | Substantially Equivalent |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | Sep 13, 2022 | Substantially Equivalent |
| K222020 | HD-550 Video Endoscope System | Sep 8, 2022 | Substantially Equivalent |
| K211882 | HD-550 Video Endoscope System | Apr 1, 2022 | Substantially Equivalent |
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Jul 30, 2020 | Substantially Equivalent |
| K182648 | X5 Series Digital Color Doppler Ultrasound System | Jan 29, 2019 | Substantially Equivalent |