Product Classification

• 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

• Class II Special Controls Guidance Document: Breast Lesion Documentation System - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible