| Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
|---|
| 510(k) Number |
K252498 |
|---|
| 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) |
|---|
| Applicant |
| Sonoscape Medical Corp. |
| Rm. 201 & 202, 12th Bldg, Shenzhen Software Park Phase Ii |
| 1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nanshan District |
|
Shenzhen,
CN
518057
|
|
| Applicant Contact |
Toki Wu |
| Correspondent |
| Sonoscape Medical Corp. |
| Rm. 201 & 202, 12th Bldg, Shenzhen Software Park Phase Ii |
| 1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nanshan District |
|
Shenzhen,
CN
518057
|
|
| Correspondent Contact |
Toki Wu |
| Regulation Number | 892.1550 |
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 08/08/2025 |
|---|
| Decision Date | 12/05/2025 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
