Data / Medical devices / United States / Hepatiq, Inc.
Hepatiq, Inc.: FDA-registered device maker in Ashland, OR, United States, 2 510(k) clearances
Hepatiq, Inc. is registered with the FDA (registration 3011527394) in Ashland, OR, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 9, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011527394
- Address
- 2305 Ashland Street Suite, Ashland, OR, United States, 97520
- Owner or operator
- Hepatiq, Inc. (10048974)
- Roles
- Manufacturer
- First device listed
- March 26, 2015
- Registered through
- 2027
- Brand names listed
- HEPATIQ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| June 9, 2016 | K161188 | HEPATIQ 1.1 | LLZ | Substantially Equivalent | Hepatiq, LLC | accessdata.fda.gov |
| December 17, 2014 | K142891 | HEPATIQ | LLZ | Substantially Equivalent | Hepatiq, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 9, 2016. 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.