510(k) K142107 ยท LLZ System, Image Processing, Radiological
ECHO TRUE 3D VIEWER
| Applicant | Echopixel, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 21, 2015 |
| Received | Aug 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142107
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2025 | Echopixel, Inc. TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX
Software versions 1.0, 1.25, and 1.35
The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.