Data / Medical devices / Taiwan / Qisda Corporation
Qisda Corporation: FDA-registered device maker in Taoyuan, Taiwan, 3 510(k) clearances
Qisda Corporation is registered with the FDA (registration 3010220244) in Taoyuan, Taiwan. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010220244
- Address
- No.159, Shan-Ying Road, Shan-Ting Li, Gueishan Dist., Taoyuan, Taiwan, 333
- Owner or operator
- Qisda Corporation (10042801)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 14, 2017
- Registered through
- 2026
- Brand names listed
- Mobile Cart (Mobile Stand)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| September 18, 2019 | K192254 | InnoSight Diagnostic Ultrasound System | IYN | Substantially Equivalent | Qisda Corporation | accessdata.fda.gov |
| August 27, 2018 | K181313 | BenQ Diagnostic Ultrasound System | IYN | Substantially Equivalent | Qisda Corporation | accessdata.fda.gov |
| December 13, 2017 | K172056 | InnoSight Diagnostic Ultrasound System | IYO | Substantially Equivalent | Qisda Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Updated September 18, 2019. 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.