Definition: To Generate Digital 3D Mammographic Images That Can Be Used For The Screening And Diagnosis Of Breast Cancer.
| Device Type ID | 5445 |
| Device Name | Digital Breast Tomosynthesis |
| Physical State | Hardware And Software For Acquiring And Reconstructing Digital Projection Images. May Incorporate Similar Equipment As Full-field Digital Mammography Systems. |
| Technical Method | Projection Images Are Acquired Over The Stationary Breast And Reconstructed To Produce Cross-sectional ¿slices¿ Through The Breast. |
| Target Area | Breast |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OTE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5445 |
| Device | Digital Breast Tomosynthesis |
| Product Code | OTE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Poor Quality Image | 95 |
Device Operates Differently Than Expected | 68 |
Device Displays Incorrect Message | 58 |
Unintended System Motion | 25 |
Switches | 18 |
Adverse Event Without Identified Device Or Use Problem | 7 |
No Display / Image | 7 |
Calibration Problem | 7 |
Collapse | 6 |
Device Operational Issue | 6 |
Device Stops Intermittently | 6 |
Shielding Failure | 5 |
Unintended Movement | 5 |
Appropriate Term/Code Not Available | 4 |
Shield | 3 |
Operating System Becomes Nonfunctional | 3 |
Leak / Splash | 3 |
Computer Software Problem | 3 |
Crack | 2 |
No Device Output | 2 |
Device Handling Problem | 2 |
Structural Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Physical Property Issue | 1 |
No Apparent Adverse Event | 1 |
Signal Artifact | 1 |
Intermittent Loss Of Power | 1 |
Computer Operating System Problem | 1 |
Detachment Of Device Component | 1 |
Motor Drive Unit | 1 |
Unintended Arm Motion | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Noise, Audible | 1 |
| Total Device Problems | 350 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Medical Solutions USA, Inc | II | Feb-25-2016 |