NKA — System, Documentation, Breast Lesion Class II
FDA product code NKA covers "System, Documentation, Breast Lesion", a Class II medical device regulated under 21 CFR 884.2990. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NKA
- Device Class
- Class II
- Regulation Number
- 884.2990
- Submission Type
- 510(k)
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.