Data / Medical devices / United States / Lumedx
Lumedx: FDA-registered device maker in Raleigh, NC, United States, 2 510(k) clearances
Lumedx is registered with the FDA (registration 3008012314) in Raleigh, NC, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 20, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008012314
- Address
- 305 Church at N Hills St 6th Floor, Raleigh, NC, United States, 27609
- Owner or operator
- Intelerad Medical Systems Incorporated (9040757)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 24, 2021
- Registered through
- 2026
- Brand names listed
- CardioPACS, HealthView ECG Manager
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 20, 2012 | K123466 | HEALTHVIEW ECG MANAGER | DQK | Substantially Equivalent | Lumedx | accessdata.fda.gov |
| July 5, 2012 | K120514 | CARDIOPACS | LLZ | Substantially Equivalent | Lumedx | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of System, Image Processing, Radiological
Updated December 20, 2012. 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.