Home / 510(k) Clearances / DEN020001

510(k) DEN020001

BREASTVIEW VISUAL MAPPING SYSTEM by Assurance Medical — Product Code NKA

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 31, 2003
Date Received: May 28, 2002
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Documentation, Breast Lesion
Device Class: Class II
Regulation Number: 884.2990
Review Panel: OB
Submission Type

A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.