K201316 is an FDA 510(k) clearance for the Bladder Scanner (Model: M3, M3-HD, M4, M4-HD). This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Suzhou Peaksonic Medical Technology Co., Ltd. (Qiandeng, Kunshan, Suzhou, CN). The FDA issued a Cleared decision on February 26, 2021, 284 days after receiving the submission on May 18, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K201316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2020 |
| Decision Date | February 26, 2021 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |