Cleared Traditional

K153736 - 3mensio Workstation

K153736 is an FDA 510(k) clearance for 3mensio Workstation, 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 151-day FDA review.

K153736 · Pie Medical Imaging BV · Radiology device
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May 2016
Decision
151d
Days
Class 2
Risk

K153736 is an FDA 510(k) clearance for the 3mensio Workstation. 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 May 27, 2016 after a review of 151 days - an extended review cycle.

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 - K153736

510(k) Number K153736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date May 27, 2016
Days to Decision 151 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
44d slower than avg
Panel avg: 107d · This submission: 151d
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 1764
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K153736.
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