| Device Type ID | 5341 |
| Device Name | System, X-ray, Mammographic |
| Regulation Description | Mammographic X-ray 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 | 892.1710 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IZH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5341 |
| Device | System, X-ray, Mammographic |
| Product Code | IZH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Mammographic X-ray System. |
| CFR Regulation Number | 892.1710 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HOLOGIC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PRECISION DYNAMCIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION DYNAMICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unintended System Motion | 12 |
Device Operational Issue | 5 |
Device Operates Differently Than Expected | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Unintended Movement | 3 |
Failure To Align | 3 |
Poor Quality Image | 2 |
Circuit Failure | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Contamination With Body Fluid | 2 |
Facilities Issue | 1 |
Power Problem | 1 |
Communication Or Transmission Problem | 1 |
Use Of Device Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Installation-Related Problem | 1 |
Calibration Problem | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Imprecision | 1 |
Positioning Problem | 1 |
| Total Device Problems | 50 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beekley Corporation | II | Jun-26-2015 |
| 2 | Hologic, Inc. | II | Jun-03-2014 |