Data / Medical devices / Taiwan / Acula Technology Corp
Acula Technology Corp: FDA-registered device maker in Luchu Taoyuan, Taiwan, 2 510(k) clearances
Acula Technology Corp is registered with the FDA (registration 3003032840) in Luchu Taoyuan, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 13, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003032840
- Address
- 11, Alley 21, Lane 20, Dashing Rd., Luchu Dist., Taoyuan City, Taiwan, Luchu Taoyuan, Taiwan, 33862
- Owner or operator
- ACULA TECHNOLOGY CORP. (10032010)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 30, 2010
- Registered through
- 2027
- Brand names listed
- LUMIN UMD3-21B01, LUMIN UMD5-21B01, ME1-19A01, ME2-24A01, ME2-24B23
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Reading, Television, Closed-Circuit | HJG | 1 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 13, 2024 | K241499 | 21.3 5MP Color LCD Display UMD5-21B01 | PGY | Substantially Equivalent | Acula Technology Corp. | accessdata.fda.gov |
| May 21, 2024 | K233336 | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | PGY | Substantially Equivalent | Acula Technology Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Display, Diagnostic Radiology
- All makers of System, Reading, Television, Closed-Circuit
- All makers of System, Digital Image Communications, Radiological
Updated June 13, 2024. 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.