Data / Medical devices / China / Microtek Computer Technology (Wu Jiang) Co, Ltd.
Microtek Computer Technology (Wu Jiang) Co, Ltd.: FDA-registered device maker in SuZhou Jiangsu, China, 1 510(k) clearance
Microtek Computer Technology (Wu Jiang) Co, Ltd. is registered with the FDA (registration 3007766685) in SuZhou Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007766685
- Address
- No.499,JiangXing East Road WuJiang Economic and Technological Development Zone, SuZhou Jiangsu, China, 215217
- Owner or operator
- Microtek International, Inc. (10029311)
- Roles
- Manufacturer
- First device listed
- August 24, 2009
- Registered through
- 2026
- Brand names listed
- M6000 Ultra, M700, M7000 Ultra, MICROTEK, MII-600 Ultra, MII-700 Ultra, MSS-600XU2L, MSS-600XU2LG and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digitizer, Image, Radiological | LMA | 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 |
|---|---|---|---|---|---|---|
| August 14, 2009 | K091288 | MEDI-6000 MEDICAL IMAGE DIGITIZER | LMA | Substantially Equivalent | Microtek International, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2009. 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.