Data / Medical devices / United States / Onepacs, LLC
Onepacs, LLC: FDA-registered device maker in Machesney Park, IL, United States, 1 510(k) clearance
Onepacs, LLC is registered with the FDA (registration 3030228575) in Machesney Park, IL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030228575
- Address
- 8777 Velocity Drive, Machesney Park, IL, United States, 61115
- Owner or operator
- OnePacs, LLC (10032310)
- Roles
- Manufacturer
- First device listed
- September 1, 2010
- Registered through
- 2026
- Brand names listed
- Teleradiology PACS Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| October 11, 2018 | K181460 | OnePacs System | LLZ | Substantially Equivalent | Onepacs, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated October 11, 2018. 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.