Cleared Traditional

K143044 - CAAS A-Valve

K143044 is an FDA 510(k) clearance for CAAS A-Valve, manufactured by Pie Medical Imaging BV. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K143044 · Pie Medical Imaging BV · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
107d
Days
Class 2
Risk

K143044 is an FDA 510(k) clearance for the CAAS A-Valve. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Pie Medical Imaging BV (Maastricht, NL). The FDA issued a Cleared decision on February 6, 2015 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Pie Medical Imaging BV devices

FDA 510(k) Submission Details - K143044

510(k) Number K143044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date February 06, 2015
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1192
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K143044.
Customer Remote Console (CRC)
K150193 · Ge Medical Systems, LLC · Mar 2015
Vitrea, Version 7.0 Medical Image Processing Software
K150258 · Vital Images, Inc. · Mar 2015
Syngo X-workplace SW VD10
K143319 · Siemens Medi Cal Solutions, Inc. · Feb 2015
IMPAX Agility
K142316 · Agfa Healthcare N.V. · Jan 2015
eSie Apps Suite
K143254 · Siemens Medical Solutions USA, Inc. · Dec 2014
Endovascular Stent Planning Software
K143079 · Vital Images, Inc. · Dec 2014