Data / Medical devices / United States / Echopixel, Inc.
Echopixel, Inc.: FDA-registered device maker in San Jose, CA, United States, 4 510(k) clearances
Echopixel, Inc. is registered with the FDA (registration 3011501361) in San Jose, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated July 17, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011501361
- Address
- 780 Montague Expy Ste 305, San Jose, CA, United States, 95131
- Owner or operator
- EchoPixel, Inc. (10048763)
- Roles
- Manufacturer
- First device listed
- February 25, 2015
- Registered through
- 2026
- Brand names listed
- EchoPixel - True 3D Viewer Software, EchoPixel True 3D Viewer, System, Image Processing, Radiological - True 3D Viewer Software, True 3D Viewer, t3D Viewer
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 |
|---|---|---|---|---|---|---|
| July 17, 2020 | K201365 | True 3D Viewer | LLZ | Substantially Equivalent | Echopixel, Inc. | accessdata.fda.gov |
| December 27, 2019 | K193149 | True 3D Viewer Software | LLZ | Substantially Equivalent | Echopixel, Inc. | accessdata.fda.gov |
| March 3, 2017 | K170167 | True 3D Viewer Software | LLZ | Substantially Equivalent | Echopixel, Inc. | accessdata.fda.gov |
| January 21, 2015 | K142107 | ECHO TRUE 3D VIEWER | LLZ | Substantially Equivalent | Echopixel, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 21, 2018 | 96674 | Class II | Ongoing | True 3D Viewer, Model: EP-00003 | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis | accessdata.fda.gov |
| April 11, 2016 | 96629 | Class II | Ongoing | 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 is responsible for mak | Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements. | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2025. 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.