Siemens Healthcare Limited (foreign exporter, Oakville Ontario, CA): 3 new FDA device listings, incl. solid state x-ray imager (flat panel/digital imager)
Siemens Healthcare Limited (Oakville Ontario, California): 3 new FDA device listings, incl. solid state x-ray imager (flat panel/digital imager). Its amount of 3 is above the median of 2 (77th percentile). Dated 100 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 3 · 77th percentile of 2,709 DeviceEstablishmentPulse records · 1.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 309 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 77th of 2,709 (median 2, 1.5x median) |
| Peer records CSV (310 CA records) | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CA first): Icu Medical, Inc. (specification developer, San Clemente, CA · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Citest Diagnostics Inc. (repackager or relabeler, VANCOUVER · Cgbio USA, Inc. (repackager or relabeler, Irvine, CA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Siemens Healthcare Limited and 310 California peers
- California DeviceEstablishmentPulse records like this one: 310
- Siemens Healthcare Limited's amount: 77th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $62,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Siemens Healthcare Limited in Oakville Ontario, California?
Siemens Healthcare Limited (Oakville Ontario, CA), a foreign exporter, added 3 FDA device listings between 2026-06-04 and 2026-07-28.
How does Siemens Healthcare Limited compare to other California DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. It is 100 days old; check the official source for later updates before acting.
Siemens Healthcare Limited vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Siemens Healthcare Limited | Oakville Ontario, CA | 3 | 77th | 2026-07-28 |
| Imperial Optical, Inc | Town Of Mount Royal, Quebec, CA | 3 | 77th | 2026-10-22 |
| Kash Sales Inc. | Richmond Hill Ontario, CA | 8 | 90th | 2026-10-16 |
| 15445361 Canada Inc. | Shawinigan Quebec, CA | 26 | 98th | 2026-10-20 |
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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.