510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254161Substantially Equivalent

Automated Aortic Stenosis Software (AutoAS)

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254161 is the FDA 510(k) clearance record for Automated Aortic Stenosis Software (AutoAS), a class II device, cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC on under FDA product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer). FDA's definition for product code POK reads: "Assist users in characterizing lesions identified on acquired medical images". FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K254161.

Clearance record

Decision date
Received
(95 days to decision)
Product code
POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Regulation
21 CFR 892.2060
Device class
Class II
Review panel
Radiology
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 3200 N Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POK

Trailing 12 months
5 clearances under product code POK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code POK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20261
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260