Cleared Traditional

K180019 - CAAS Workstation

K180019 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 121-day FDA review.

K180019 · Pie Medical Imaging BV · Radiology device
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May 2018
Decision
121d
Days
Class 2
Risk

K180019 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 May 3, 2018 after a review of 121 days - within the typical 510(k) review window.

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 - K180019

510(k) Number K180019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date May 03, 2018
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
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
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