Carestream Health, Inc., Global R&D Center
Registered establishment in Shanghai, China. 8 device types.
Carestream Health, Inc., Global R&D Center is a specification developer holding a current FDA establishment registration. The registration covers Table, Radiologic, System, X-Ray, Stationary and 6 other device types. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | CARESTREAM HEALTH, INC., GLOBAL R&D CENTER |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005778458 |
| FEI number | 3005778458 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Bldg 15 |
| Postal code | 201206 |
| Country | China |
Group
Carestream Health, Inc., Global R&D Center is one of 2 plants registered under Carestream Health, Inc..
| Plant | City | Device types |
|---|---|---|
| Rayco (Xiamen) Medical Products Company Limited | Xiamen | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | Class 1 | X-RAY Generator System (REF: QG-40, QG-40-2, QG-40-3, QG-40-SE), X-RAY Generator System (REF: QG-50-2, QG-50, QG-50-SE, QG-65, QG-80) | 2011 | 6 |
| Holder, Radiographic Cassette, Wall-Mounted | Class 1 | QR-Lch,qt-Lch,qt-LCH-P,QT-TCH, QW-420 | 2011 | 6 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | TRIMAX 35C Detector, Focus 35C Detector, Lux HD 35 Detector, DR-FIT X-ray System, Carestream DRX-Evolution Plus, DRX-Compass X-ray System and 1 more | 2020 | 13 |
| System, Image Processing, Radiological | Class 2 | Carestream Image Suite | 2011 | 16 |
| System, X-Ray, Stationary | Class 2 | DRX-Ascend System, Lux HD 35 Detector, DR-FIT X-ray System, Carestream DRX-Evolution Plus, DRX-Compass X-ray System, Lux HD 43 Detector | 2011 | 7 |
| Table, Radiographic, Non-Tilting, Powered | Class 2 | QT-740, QT-750 | 2011 | 3 |
| Table, Radiologic | Class 2 | SPT2 Radiographic Table, Carestream DR Long Length Imaging Stand | 2010 | 4 |
| Tube Mount, X-Ray, Diagnostic | Class 1 | QS-500 | 2011 | 5 |
Clearances
No clearance names Carestream Health, Inc., Global R&D Center as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250954 | 2026-01-20 | KPR | Traditional | Carestream Health, Inc. |
| K192512 | 2019-10-16 | MQB | Special | Iray Technology Taicang, Ltd. |
| K100094 | 2010-03-11 | LLZ | Traditional | Carestream Heatlh, Inc. |
| K011486 | 2001-06-20 | KPR | Traditional | Quantum Medical Imaging, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 400+ |
|---|---|
| Main products | R&D services (foreign multinational R&D center) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.