Cleared Traditional

K151780 - CAAS Workstation

K151780 is the FDA 510(k) clearance for CAAS Workstation by Pie Medical Imaging BV. It is a Class 2 Radiology device (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

Submission Details

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
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.

Device Classification

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 98
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K151780.
GLOW800
K181537 · Leica Microsystems (Schweiz) AG · Sep 2018
CAAS Workstation
K180019 · Pie Medical Imaging BV · May 2018
YELLOW 560 Fluorescence Module
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ALLURA XPER FD OR TABLE SERIES
K130842 · Philips Medical Systems Nederland B.V. · May 2013
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
K113034 · Ge Healthcare · Dec 2011
INTEGRATED INNOVA - S5I SYSTEM OPTION
K111209 · Ge Healthcare · Jul 2011