# GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC (manufacturer, Waukesha, WI): 5 new FDA device listings, incl. transducer, ultrasonic, diagnostic

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC |
| Owner / operator | GE HealthCare Technologies Inc. |
| Role | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Waukesha, WI, US |
| New listings | 5 |
| Devices | Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting; Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
| Product codes | ITX, IYN, QIH, ITO, QJU |
| Device classes | Class I, Class II |
| Medical specialties | Radiology, Physical Medicine |
| Brand names | C1-5-RS; Venue Go; L8-18t-RS; L10-22-RS; 9L-RS; M5Sc-RS; 12L-RS; 6Tc-RS |
| First new listing | 2026-08-10 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 3032008018 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.