Cleared Traditional

AV Vascular

K253735 · Philips Medical Systems Nederland B.V. · Radiology

Jan 2026

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K253735 is an FDA 510(k) clearance for the AV Vascular, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on January 22, 2026, 59 days after receiving the submission on November 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K253735 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2025
Decision Date	January 22, 2026
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QIH — Automated Radiological Image Processing Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.