The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for S50 Digital Color Doppler Ultrasound System.
| Device ID | K152854 |
| 510k Number | K152854 |
| Device Name: | S50 Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE MEDICAL CORP. 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building Yuquan Road, Nanshan Shenzhen, CN 518051 |
| Contact | Toki Wu |
| Correspondent | Toki Wu SONOSCAPE MEDICAL CORP. 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building Yuquan Road, Nanshan Shenzhen, CN 518051 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868620141 | K152854 | 000 |
| 06945868601355 | K152854 | 000 |
| 06945868601331 | K152854 | 000 |
| 06945868601324 | K152854 | 000 |
| 06945868601317 | K152854 | 000 |
| 06945868601300 | K152854 | 000 |
| 06945868601294 | K152854 | 000 |
| 06945868601249 | K152854 | 000 |
| 06945868601232 | K152854 | 000 |
| 06945868601225 | K152854 | 000 |
| 06945868601218 | K152854 | 000 |
| 06945868601164 | K152854 | 000 |
| 06945868600464 | K152854 | 000 |
| 06945868600457 | K152854 | 000 |
| 06945868600419 | K152854 | 000 |
| 06945868600402 | K152854 | 000 |
| 06945868600372 | K152854 | 000 |
| 06945868600365 | K152854 | 000 |
| 06945868601362 | K152854 | 000 |
| 06945868601386 | K152854 | 000 |
| 06945868620134 | K152854 | 000 |
| 06945868615017 | K152854 | 000 |
| 06945868615000 | K152854 | 000 |
| 06945868602208 | K152854 | 000 |
| 06945868602192 | K152854 | 000 |
| 06945868602154 | K152854 | 000 |
| 06945868602000 | K152854 | 000 |
| 06945868601485 | K152854 | 000 |
| 06945868601478 | K152854 | 000 |
| 06945868601461 | K152854 | 000 |
| 06945868601454 | K152854 | 000 |
| 06945868601447 | K152854 | 000 |
| 06945868601430 | K152854 | 000 |
| 06945868601423 | K152854 | 000 |
| 06945868601416 | K152854 | 000 |
| 06945868601409 | K152854 | 000 |
| 06945868601393 | K152854 | 000 |
| 06945868600105 | K152854 | 000 |