510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254115Substantially Equivalent

ArteraAI Breast

Artera, Los Altos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K254115 is the FDA 510(k) clearance record for ArteraAI Breast, a class II device, cleared for Artera, Inc. on under FDA product code SHW (Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis). FDA's definition for product code SHW reads: "A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from breast cancer specimens prepared from formalin fixed paraffin-embedded (FFPE)...". FDA records list 2 510(k) clearances for Artera, Inc., from to . As of , FDA records show no recalls naming K254115.

Clearance record

Decision date
Received
(136 days to decision)
Product code
SHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
Regulation
21 CFR 864.3755
Device class
Class II
Review panel
Pathology
Applicant
Artera, Inc. 108 1st St., Los Altos CA
510(k) summary
Statement
Third party review
No

Clearances, product code SHW

Trailing 12 months
2 clearances under product code SHW in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260