# Fujita Co., Ltd. (foreign exporter, Chiyoda-ku Tokyo, JP): 2 new FDA device listings, incl. digital breast tomosynthesis

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | Fujita Co., Ltd. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Chiyoda-ku Tokyo, JP |
| New listings | 2 |
| Devices | Digital Breast Tomosynthesis; Densitometer, Bone |
| Product codes | OTE, KGI |
| Device classes | Class II, Class III |
| Medical specialties | Radiology |
| Brand names | Hologic Dimensions 3D Mammography; Hologic Horizon Bone Densitometer |
| First new listing | 2026-06-10 |
| Latest new listing | 2026-06-10 |
| FDA registration number | 3036666444 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.

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.