510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN020001Unknown

Breastview Visual Mapping System

Assurance Medical, Washington DC / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN020001 is the FDA 510(k) clearance record for BREASTVIEW VISUAL MAPPING SYSTEM, a class II device, cleared for Assurance Medical on under FDA product code NKA (System, Documentation, Breast Lesion). FDA's definition for product code NKA reads: "A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam". FDA records list one 510(k) clearance for Assurance Medical. As of , FDA records show no recalls naming DEN020001.

Clearance record

Decision date
Received
(248 days to decision)
Product code
NKA System, Documentation, Breast Lesion
Regulation
21 CFR 884.2990
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Assurance Medical 555 Thirteenth St. NW, Washington DC
Third party review
No

Clearances, product code NKA

Trailing 12 months

FDA records hold no clearances under product code NKA in the trailing twelve months.

FDA records show no clearances under product code NKA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260