Data / Medical devices / Taiwan / Amcad Biomed Corporation
Amcad Biomed Corporation: FDA-registered device maker in Taipei, Taiwan, 3 510(k) clearances
Amcad Biomed Corporation is registered with the FDA (registration 3015218501) in Taipei, Taiwan. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 8, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015218501
- Address
- 5F., No.167, Fu Hsing N. Rd., Taipei 105, Taiwan, R.O.C., Taipei, Taiwan, 105
- Owner or operator
- AmCad BioMed Corporation (10059547)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- January 31, 2019
- Registered through
- 2026
- Brand names listed
- AmCAD-UO, AmCAD-US, AmCAD-UT, Head & Neck Laser Alignment Tool
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Contract manufacturer, 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 8, 2021 | K203555 | AmCAD-UT | QIH | Substantially Equivalent | Amcad Biomed Corporation | accessdata.fda.gov |
| December 28, 2018 | K180867 | AmCAD-UO | LLZ | Substantially Equivalent | Amcad Biomed Corporation | accessdata.fda.gov |
| May 30, 2017 | K162574 | AmCAD-US | LLZ | Substantially Equivalent | Amcad Biomed Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Monitor, Patient Position, Light-Beam
- All makers of Automated Radiological Image Processing Software
Updated September 8, 2021. 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.