Voyant System— 510(k) K191579

Name: FDA 510(k) clearance K191579
Creator: U.S. Food and Drug Administration
Published: 2019-07-11

Substantially Equivalent

Viseon, Inc.

FDA 510(k) clearance K191579 for Voyant System, Substantially Equivalent on 2019-07-11. Applicant: Viseon, Inc.. Device class: 2.

Clearance details

Applicant: Viseon, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2019-06-14
Decision date: 2019-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Viseon, Inc.

view all

K181885 — Voyant System2018-10-02

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.