The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for S9 Portable Digital Color Doppler Ultrasound System.
| Device ID | K152165 |
| 510k Number | K152165 |
| Device Name: | S9 Portable 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868699031 | K152165 | 000 |
| 06945868601614 | K152165 | 000 |
| 06945868601607 | K152165 | 000 |
| 06945868601584 | K152165 | 000 |
| 06945868601577 | K152165 | 000 |
| 06945868601553 | K152165 | 000 |
| 06945868601546 | K152165 | 000 |
| 06945868601539 | K152165 | 000 |
| 06945868601522 | K152165 | 000 |
| 06945868601515 | K152165 | 000 |
| 06945868601508 | K152165 | 000 |
| 06945868600341 | K152165 | 000 |
| 06945868600228 | K152165 | 000 |
| 06945868600174 | K152165 | 000 |
| 06945868600167 | K152165 | 000 |
| 06945868601621 | K152165 | 000 |
| 06945868601638 | K152165 | 000 |
| 06945868699000 | K152165 | 000 |
| 06945868602628 | K152165 | 000 |
| 06945868601751 | K152165 | 000 |
| 06945868601744 | K152165 | 000 |
| 06945868601737 | K152165 | 000 |
| 06945868601720 | K152165 | 000 |
| 06945868601713 | K152165 | 000 |
| 06945868601706 | K152165 | 000 |
| 06945868601690 | K152165 | 000 |
| 06945868601683 | K152165 | 000 |
| 06945868601676 | K152165 | 000 |
| 06945868601669 | K152165 | 000 |
| 06945868601652 | K152165 | 000 |
| 06945868601645 | K152165 | 000 |
| 06945868600068 | K152165 | 000 |