Definition: A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam.
| Device Type ID | 4039 |
| Device Name | System, Documentation, Breast Lesion |
| Regulation Description | Breast Lesion Documentation System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.2990 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NKA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4039 |
| Device | System, Documentation, Breast Lesion |
| Product Code | NKA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Breast Lesion Documentation System. |
| CFR Regulation Number | 884.2990 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
UE LIFESCIENCES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |