# Siemens Healthcare Limited (foreign exporter, Oakville Ontario, CA): 3 new FDA device listings, incl. solid state x-ray imager (flat panel/digital imager)

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Siemens Healthcare Limited |
| Owner / operator | Siemens Medical Solutions USA, Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Oakville Ontario, CA |
| New listings | 3 |
| Devices | Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Stationary; Digital Breast Tomosynthesis |
| Product codes | MQB, KPR, OTE |
| Device classes | Class II, Class III |
| Medical specialties | Radiology |
| Brand names | Carestream DRX-Evolution Plus X-ray System; Carestream DRX-Compass X-ray System; Carestream Lux HD 43 Detector; Carestream Lux HD 35 Detector; Selenia Dimensions/3Dimensions |
| First new listing | 2026-06-04 |
| Latest new listing | 2026-07-28 |
| FDA registration number | 3012127758 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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.