The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for X5 Digital Color Doppler Ultrasound System.
| Device ID | K160258 |
| 510k Number | K160258 |
| Device Name: | X5 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 | 2016-02-01 |
| Decision Date | 2016-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868695002 | K160258 | 000 |
| 06945868601836 | K160258 | 000 |
| 06945868601829 | K160258 | 000 |
| 06945868601812 | K160258 | 000 |
| 06945868601805 | K160258 | 000 |
| 06945868601799 | K160258 | 000 |
| 06945868601782 | K160258 | 000 |
| 06945868601775 | K160258 | 000 |
| 06945868601768 | K160258 | 000 |