| Device Type ID | 5394 |
| Device Name | Full Field Digital, System, X-ray, Mammographic |
| Regulation Description | Full-field Digital Mammography System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1715 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MUE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5394 |
| Device | Full Field Digital, System, X-ray, Mammographic |
| Product Code | MUE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Full-field Digital Mammography System. |
| CFR Regulation Number | 892.1715 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADANI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM MEDICAL SYSTEMS, USA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
PLANMED OY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS CAPITAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS MEDICAL SOLUTIONS USA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 91 |
Device Displays Incorrect Message | 49 |
Unintended System Motion | 35 |
Poor Quality Image | 35 |
Device Operates Differently Than Expected | 31 |
Unintended Movement | 17 |
Device Stops Intermittently | 8 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Switches | 4 |
Mechanical Problem | 4 |
Collapse | 3 |
Detachment Of Device Component | 3 |
Shielding Failure | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Power Problem | 2 |
Device Component Or Accessory | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Physical Property Issue | 2 |
Image Display Error / Artifact | 2 |
Detachment Of Device Or Device Component | 2 |
Computer Software Problem | 2 |
Erratic Or Intermittent Display | 1 |
Imprecision | 1 |
Positioning Problem | 1 |
Component Falling | 1 |
Insufficient Information | 1 |
Break | 1 |
Crack | 1 |
Display Or Visual Feedback Problem | 1 |
Calibration Problem | 1 |
Electrical Shorting | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Appropriate Term/Code Not Available | 1 |
Structural Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Human-Device Interface Problem | 1 |
Fire | 1 |
Communication Or Transmission Problem | 1 |
Shield | 1 |
Failure To Service | 1 |
| Total Device Problems | 327 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beekley Corporation | III | Jun-13-2014 |
| 2 | Fujifilm Medical System USA, Inc. | II | May-21-2014 |
| 3 | Fujifilm Medical Systems U.S.A., Inc. | II | Feb-20-2018 |
| 4 | Fujifilm Medical Systems U.S.A., Inc. | II | Jan-17-2018 |
| 5 | Fujifilm Medical Systems U.S.A., Inc. | II | Aug-30-2016 |
| 6 | Fujifilm Medical Systems U.S.A., Inc. | II | May-06-2015 |
| 7 | Hologic, Inc. | II | Dec-27-2018 |
| 8 | Hologic, Inc. | II | Jun-03-2014 |
| 9 | Siemens Medical Solutions USA, Inc | II | Jan-31-2017 |
| 10 | Siemens Medical Solutions USA, Inc | II | Dec-06-2014 |
| 11 | Siemens Medical Solutions USA, Inc | II | Oct-17-2014 |
| 12 | Siemens Medical Solutions USA, Inc | II | May-20-2014 |