The following data is part of a premarket notification filed by Avantsonic Technology Co., Ltd. with the FDA for Bladder Scanner (model: Padscan Ds3, Padscan Z3, Padscan Z5).
| Device ID | K171528 |
| 510k Number | K171528 |
| Device Name: | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Avantsonic Technology Co., Ltd. No.394, Jingdongfang Avenue Beibei District Chongqing, CN 400714 |
| Contact | Cuiling Wu |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square No. 18, Taizi Road Nanshan District, Shenzhen, CN 518067 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2018-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971759810025 | K171528 | 000 |
| 06971759810018 | K171528 | 000 |