| Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
|---|
| 510(k) Number |
K254028 |
|---|
| Device Name |
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) |
|---|
| 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 | 12/16/2025 |
|---|
| Decision Date | 05/15/2026 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
