# Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K261933): 510(k) cleared for GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261933 |
| Device | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 |
| Applicant | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC |
| Specialty / panel | Radiology |
| Product code | IYN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-09 |
| Decision date | 2026-10-02 |
| Review time (days) | 115 |
| Third-party review | No |
| Applicant location | Waukesha, WI, US |

## Why this score
- Fast 115-day review: this device is a strong predicate for similar products.
- Posted 34 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261933). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.