510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240068Unknown

ArteraAI Prostate

Artera, Los Altos CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240068 is the FDA 510(k) clearance record for ArteraAI Prostate, a class II device, cleared for Artera, Inc. on under FDA product code SFH (Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis). FDA's definition for product code SFH reads: "A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and...". FDA records list 2 510(k) clearances for Artera, Inc., from to . As of , FDA records show no recalls naming DEN240068.

Clearance record

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

Clearances, product code SFH

Trailing 12 months

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

FDA records show no clearances under product code SFH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFH, 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