# GE Healthcare Japan Corporation (manufacturer, HINO-SHI Tokyo, JP): 19 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | GE Healthcare Japan Corporation |
| Owner / operator | GE HealthCare Technologies Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | HINO-SHI Tokyo, JP |
| New listings | 19 |
| Devices | System, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Automated Radiological Image Processing Software; Twister, Brace Setting |
| Product codes | IYN, ITX, IYO, QIH, ITO |
| Device classes | Class I, Class II |
| Medical specialties | Radiology, Physical Medicine |
| Brand names | E8Cs-RS; P6D; IC9-RS; 12L-RS; ML6-15-RS; LOGIQ Focus; 4C-RS; L4-20t-RS |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-10-07 |
| FDA registration number | 9612283 |
| 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.
- 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.