Cleared Traditional

K945540 - CAAS II

K945540 is an FDA 510(k) clearance for CAAS II, manufactured by Pie Medical Equipment B.V.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K945540 · Pie Medical Equipment B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
226d
Days
Class 2
Risk

K945540 is an FDA 510(k) clearance for the CAAS II. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Pie Medical Equipment B.V. (Maastricht, NL). The FDA issued a Cleared decision on June 28, 1995 after a review of 226 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 Equipment B.V. devices

FDA 510(k) Submission Details - K945540

510(k) Number K945540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date June 28, 1995
Days to Decision 226 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 107d · This submission: 226d
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 143
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K945540.
HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
K945400 · Hitachi Medical Corp. of America · Nov 1995
ANGIOREX
K954309 · Toshiba Medical Systems · Oct 1995
PHILIPS EASYVISION
K952704 · Philips Medical Systems, Inc. · Jul 1995
UNICATH LLU ANGIOGRAPHIC SYSTEM
K945449 · Xre Corp. · Feb 1995
CEILING SUSPENDED C-ARM SUPPORT MH-100
K943545 · Shimadzu Medical Systems · Feb 1995
ADVANTX LCA
K945375 · GE Medical Systems · Jan 1995