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FDR-3000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis,…
FDR-3000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | MUE |
| Device type | Full Field Digital, System, X-Ray, Mammographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1715 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K133972 |
| Record published | 2016-09-16 |
| Record revised | 2024-05-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FDR-3000AWS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Selenia® Dimensions® | Hologic, Inc. | 47 |
| Selenia Ffdm | Hologic, Inc. | 29 |
| Full Field Digital, System, X-Ray, Mammographic | GE Medical Systems, LLC | 10 |
| Senographe Pristina | GE Medical Systems, LLC | 10 |
| Directview CR Mammography Cassette with EHR-M Screen | Carestream Health, Inc. | 10 |
| Giotto Class | IMS Giotto SPA | 6 |
| Directview CR Mammography Cassette with EHR-M3 Screen | Carestream Health, Inc. | 5 |
| Giotto Image 3DL | I.M.S. Internazionale Medico Scientifica SRL | 5 |
| CR-IR 392 | Fujifilm Corporation | 3 |
| Giotto Image | IMS Giotto SPA | 3 |
| CR HD5.0 AEC Cassette | Agfa Healthcare Inc. | 3 |
| Directview CR Mammography Cassette with HR Screen | Carestream Health, Inc. | 3 |
Showing 12 of 103. All products under Full Field Digital, System, X-Ray, Mammographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212873 | 2022-05-27 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2017-08-04 | Class II | Software design | FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but v | 71 units (68 units Domestic. 3 units Foreign) in total | 2019-04-01 |
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2017-07-14 | Class II | Employee error | There was a case that the swivel arm went down unintentionally when it was moved up/down. | 15 US 1 OUS | 2018-07-20 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P080018 | 2010-11-03 | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY | Carestream Health, Inc. |
| P050014 | 2009-01-09 | FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE | Fujifilm Medical System U.S.A., Inc. |
| P990066 | 2007-08-01 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL | GE Healthcare GmbH |
| P030010 | 2004-08-20 | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Siemens Medical Solution |
| P010017 | 2004-05-12 | SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. |
| P010025 | 2003-09-24 | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. |
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.