Fujifilm Imaging System (Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 3 device types.
Fujifilm Imaging System (Suzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Camera, Multi Format, Radiological, Full Field Digital, System, X-Ray, Mammographic and 1 other device type. Its earliest product listing with the FDA dates from 2006.
Registration
| Registered name | FUJIFILM Imaging System (Suzhou) Co., Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008787461 |
| FEI number | 3008787461 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 138 Chang Jiang Road |
| Postal code | 215011 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | Class 2 | DryPix Lite (DRYPIX2000), DRYPIX Smart (DRYPIX6000), Drypix Edge (Drypix 8000), FUJIFILM DryPix Laser Imager | 2006 | 2 |
| Full Field Digital, System, X-Ray, Mammographic | Class 2 | FCR PRIMA Tm (CR-IR392), Aspire CRm (CR-IR359) | 2012 | 1 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | FCR Prima T2(CR-IR392), FCR Prima T(CR-IR392), FCR Carbon (CR-IR357), FCR XL-2 (CR-IR359), FCR Carbon XL-2 (CR-IR359), FCR PRIMA Tm(CR-IR392) and 2 more | 2008 | 13 |
Clearances
No clearance names Fujifilm Imaging System (Suzhou) Co., Ltd. as applicant. 4 are held by another company 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 |
|---|---|---|---|---|
| K111646 | 2011-12-08 | MUE | Traditional | Fujifilm Medical System U.S.A., Inc. |
| K042023 | 2004-08-25 | MQB | Traditional | Fujifilm Medical System U.S.A., Inc. |
| K033377 | 2004-01-09 | LMC | Traditional | Fujifilm Medical System U.S.A., Inc. |
| K962967 | 1996-10-28 | LMC | Traditional | Fujifilm Medical System U.S.A., Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Factory area | 130,000 square meters |
| Main products | X-ray diagnosis devices, ultrasonic diagnostic equipment, MRI systems, bone densitometers, CT image diagnostic devices |
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.
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