Data / Medical devices / United States / Epsilon Imaging, Inc.
Epsilon Imaging, Inc.: FDA-registered device maker in Ann Arbor, MI, United States, 1 510(k) clearance
Epsilon Imaging, Inc. is registered with the FDA (registration 3008840981) in Ann Arbor, MI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008840981
- Address
- 333 Jackson Plaza Suite 100, Ann Arbor, MI, United States, 48103
- Owner or operator
- Ultrasound Medical Devices, Inc. (dba Epsilon Imaging Inc.) (10034861)
- Roles
- Manufacturer
- First device listed
- December 15, 2011
- Registered through
- 2026
- Brand names listed
- EchoInsight
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 |
|---|---|---|---|---|---|---|
| May 27, 2011 | K110447 | ECHOINSIGHT | LLZ | Substantially Equivalent | Ultrasound Medical Devices, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 27, 2011. 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.