Cleared Special

K060941 - CAAS MRV VERSION 3.0

K060941 is an FDA 510(k) clearance for CAAS MRV VERSION 3.0, manufactured by Pie Medical Imaging BV. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 13-day FDA review.

K060941 · Pie Medical Imaging BV · Radiology device
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Apr 2006
Decision
13d
Days
Class 2
Risk

K060941 is an FDA 510(k) clearance for the CAAS MRV VERSION 3.0. 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 (Eden Prairie, US). The FDA issued a Cleared decision on April 19, 2006 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 - K060941

510(k) Number K060941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date April 19, 2006
Days to Decision 13 days
Submission Type Special
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
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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
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