Data / Medical devices / Taiwan / Ebm Technologies, Inc.
Ebm Technologies, Inc.: FDA-registered device maker in Taipei, Taiwan, 6 510(k) clearances
Ebm Technologies, Inc. is registered with the FDA (registration 3004722076) in Taipei, Taiwan. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 27, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004722076
- Address
- 5F, 516, Sec.1, Nei Hu RD., Taipei, Taiwan, --
- Owner or operator
- EBM TECHNOLOGIES Inc. (9050440)
- Roles
- Manufacturer
- First device listed
- June 6, 2002
- Registered through
- 2027
- Brand names listed
- BC800 3G, EBM AWAN, EBM PACS Server, EBM VS 1000, EPS Pi, MobiPACS" App 1.2.1, Rad@, MobiPACS App, Pangea Dental and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| January 27, 2017 | K162285 | EBM iDO Viewer 1.2.1 | LLZ | Substantially Equivalent | Ebm Technologies Incorporated | accessdata.fda.gov |
| December 18, 2014 | K142514 | UniWeb 8.0 | LLZ | Substantially Equivalent | Ebm Technologies Incorporated | accessdata.fda.gov |
| September 18, 2014 | K140399 | EBM IDO VIEWER | LLZ | Substantially Equivalent | Ebm Technologies USA, LLC | accessdata.fda.gov |
| July 23, 2007 | K071166 | UNIWEB, VERSION 5.0 | LLZ | Substantially Equivalent | Electronic Business Machine Co., Ltd. (Ebm) | accessdata.fda.gov |
| October 31, 2006 | K062743 | UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 | LLZ | Substantially Equivalent | Electronic Business Machine Co., Ltd. (Ebm) | accessdata.fda.gov |
| January 7, 2003 | K023394 | UNISIGHT SYSTEM WITH UNIGATE | LLZ | Substantially Equivalent | Electronic Business Machine Co., Ltd. (Ebm) | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
- All makers of Scale, Stand-On, Patient
- All makers of Medical Device Data System
- All makers of Device, Digital Image Storage, Radiological
Updated January 27, 2017. 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.