Data / Medical devices / United States / Viseon, Inc.
Viseon, Inc.: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Viseon, Inc. is registered with the FDA (registration 3014388471) in Irvine, CA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014388471
- Address
- 13700 Alton Parkway Suite 167, Irvine, CA, United States, 92618
- Owner or operator
- Viseon, Inc. (10057389)
- Roles
- Manufacturer
- First device listed
- March 28, 2018
- Registered through
- 2026
- Brand names listed
- Hawkeye, Hubble EXCITE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Instrument | FSQ | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | 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 11, 2019 | K191579 | Voyant System | HRX | Substantially Equivalent | Viseon, Inc. | accessdata.fda.gov |
| October 2, 2018 | K181885 | Voyant System | HRX | Substantially Equivalent | Viseon, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Microscope, Surgical, General & Plastic Surgery
- All makers of Retractor
- All makers of Arthroscope
- All makers of Light, Surgical, Instrument
Updated July 11, 2019. 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.