Device |
system, documentation, breast lesion |
Regulation Description |
Breast lesion documentation system. |
Definition |
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam. |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | NKA |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.2990
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |