Aidia
The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer. This unit is intended for use in the same clinical…
The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer. This unit is intended for use in the same clinical applications as traditional screen film mammography systems.
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 | Drtech Corporation, South Korea |
|---|---|
| FDA product code | MUE |
| Device type | Full Field Digital, System, X-Ray, Mammographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1715 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K220073 |
| Record published | 2023-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RMF-2000 | 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 |
|---|---|
| K220073 | 2023-01-26 |
| K170930 | 2017-04-27 |
| K162670 | 2017-02-23 |
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.