Data / Medical devices / China / Suzhou Peaksonic Medical Technology Co., Ltd.
Suzhou Peaksonic Medical Technology Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Suzhou Peaksonic Medical Technology Co., Ltd. is registered with the FDA (registration 3015972810) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015972810
- Address
- 2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park Qiandeng Town, Kunshan, Suzhou Jiangsu, China, 215341
- Owner or operator
- Suzhou PeakSonic Medical Technology Co., Ltd. (10061380)
- Roles
- Manufacturer
- First device listed
- October 13, 2019
- Registered through
- 2026
- Brand names listed
- Bladder Scanner (Models: M2, M2-W, M1, M1-W), Bladder Scanner M3, M3-HD, M4, M4-HD, Bladder Scanner, Model Name: M5, M5 Lite, Portable Blader Scanner 259-M2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2022 | K213488 | Bladder Scanner, Model Name:M5 | IYO | Substantially Equivalent | Suzhou Peaksonic Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 26, 2021 | K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | IYO | Substantially Equivalent | Suzhou Peaksonic Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 22, 2019 | K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | IYO | Substantially Equivalent | Suzhou Lischka Medtech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated July 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.