The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for E5 Series Digital Color Doppler Ultrasound System.
| Device ID | K170303 |
| 510k Number | K170303 |
| Device Name: | E5 Series 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 | 2017-01-31 |
| Decision Date | 2017-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868695040 | K170303 | 000 |
| 06945868602307 | K170303 | 000 |
| 06945868602291 | K170303 | 000 |
| 06945868602277 | K170303 | 000 |
| 06945868602260 | K170303 | 000 |
| 06945868602253 | K170303 | 000 |
| 06945868602246 | K170303 | 000 |
| 06945868602239 | K170303 | 000 |
| 06945868602222 | K170303 | 000 |
| 06945868602215 | K170303 | 000 |
| 06945868601850 | K170303 | 000 |
| 06945868622091 | K170303 | 000 |
| 06945868691004 | K170303 | 000 |
| 06945868695033 | K170303 | 000 |
| 06945868695026 | K170303 | 000 |
| 06945868695019 | K170303 | 000 |
| 06945868693039 | K170303 | 000 |
| 06945868693022 | K170303 | 000 |
| 06945868693015 | K170303 | 000 |
| 06945868692025 | K170303 | 000 |
| 06945868692018 | K170303 | 000 |
| 06945868692001 | K170303 | 000 |
| 06945868691011 | K170303 | 000 |
| 06945868601843 | K170303 | 000 |