Cleared Traditional

K151780 - CAAS Workstation

K151780 is an FDA 510(k) clearance for CAAS Workstation, manufactured by Pie Medical Imaging BV. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K151780 · Pie Medical Imaging BV · Radiology device
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Mar 2016
Decision
254d
Days
Class 2
Risk

K151780 is an FDA 510(k) clearance for the CAAS Workstation. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Pie Medical Imaging BV (Maastricht, NL). The FDA issued a Cleared decision on March 11, 2016 after a review of 254 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pie Medical Imaging BV devices

FDA 510(k) Submission Details - K151780

510(k) Number K151780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date March 11, 2016
Days to Decision 254 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
147d slower than avg
Panel avg: 107d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 149
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K151780.
CAAS Workstation
K180019 · Pie Medical Imaging BV · May 2018
YELLOW 560 Fluorescence Module
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Leica FL560
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LEICA FL800
K141136 · Leica Biosystems Richmond · Aug 2014
PDE-NEO
K133719 · Hamamatsu Photonics K.K. · Mar 2014
CAAS WORKSTATION
K133993 · Pie Medical Imaging · Mar 2014