Data / Medical devices / China / FUJIFILM Imaging System (Suzhou) Co., Ltd.
FUJIFILM Imaging System (Suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 4 510(k) clearances
FUJIFILM Imaging System (Suzhou) Co., Ltd. is registered with the FDA (registration 3008787461) in Suzhou Jiangsu, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 8, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008787461
- Address
- 138 Chang Jiang Road New District, Suzhou Jiangsu, China, 215011
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Manufacturer
- First device listed
- October 5, 2006
- Registered through
- 2026
- Brand names listed
- Aspire CRm (CR-IR359), DRYPIX EDGE (DRYPIX 8000), DRYPIX Smart (DRYPIX6000), DryPix Lite (DRYPIX2000), FCR CARBON (CR-IR357), FCR CARBON XL-2 (CR-IR359), FCR PRIMA Tm (CR-IR392), FCR PRIMA Tm(CR-IR392) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Multi Format, Radiological | LMC | 2 | Manufacturer | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 8, 2011 | K111646 | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR | MUE | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| August 25, 2004 | K042023 | FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER | MQB | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| January 9, 2004 | K033377 | FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L | LMC | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
| October 28, 1996 | K962967 | FUJI MEDICAL DRY IMAGER FM-DP 2636 | LMC | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Multi Format, Radiological
- All makers of Full Field Digital, System, X-Ray, Mammographic
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated December 8, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.