The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for X5 Series Digital Color Doppler Ultrasound System.
| Device ID | K182648 |
| 510k Number | K182648 |
| Device Name: | X5 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 | 2018-09-24 |
| Decision Date | 2019-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868695507 | K182648 | 000 |
| 06945868603120 | K182648 | 000 |
| 06945868603113 | K182648 | 000 |
| 06945868603106 | K182648 | 000 |
| 06945868603090 | K182648 | 000 |
| 06945868603083 | K182648 | 000 |
| 06945868603076 | K182648 | 000 |
| 06945868603069 | K182648 | 000 |
| 06945868603052 | K182648 | 000 |
| 06945868603045 | K182648 | 000 |
| 06945868603038 | K182648 | 000 |
| 06945868603021 | K182648 | 000 |
| 06945868603014 | K182648 | 000 |
| 06945868603007 | K182648 | 000 |
| 06945868603137 | K182648 | 000 |
| 06945868603144 | K182648 | 000 |
| 06945868695408 | K182648 | 000 |
| 06945868695309 | K182648 | 000 |
| 06945868695200 | K182648 | 000 |
| 06945868695101 | K182648 | 000 |
| 06945868620899 | K182648 | 000 |
| 06945868603229 | K182648 | 000 |
| 06945868603212 | K182648 | 000 |
| 06945868603205 | K182648 | 000 |
| 06945868603199 | K182648 | 000 |
| 06945868603182 | K182648 | 000 |
| 06945868603175 | K182648 | 000 |
| 06945868603168 | K182648 | 000 |
| 06945868603151 | K182648 | 000 |
| 06945868602901 | K182648 | 000 |