510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190575Substantially Equivalent

iBreastExam

UE Lifesciences Inc., Philadelphia PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190575 is the FDA 510(k) clearance record for iBreastExam, a class II device, cleared for Ue Lifesciences, Inc. 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 3 510(k) clearances for Ue Lifesciences, Inc., from to . As of , FDA records show no recalls naming K190575.

Clearance record

Decision date
Received
(132 days to decision)
Product code
NKA System, Documentation, Breast Lesion
Regulation
21 CFR 884.2990
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ue Lifesciences, Inc. 3401 Market St., Suite 200, Philadelphia PA
510(k) summary
Summary PDF
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