Cleared Traditional

K982203 - CAAS II LVA BIPLANE OPTION

K982203 is an FDA 510(k) clearance for CAAS II LVA BIPLANE OPTION, 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 22-day FDA review.

K982203 · Pie Medical Equipment B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
22d
Days
Class 2
Risk

K982203 is an FDA 510(k) clearance for the CAAS II LVA BIPLANE OPTION. 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 July 14, 1998 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pie Medical Equipment B.V. devices

FDA 510(k) Submission Details - K982203

510(k) Number K982203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date July 14, 1998
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
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 142
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K982203.
HITACHI VERSIFLEX
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THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
K974679 · Medcon , Ltd. · Mar 1998
ADVANTX LCN, ADVANTX LCLP
K974367 · GE Medical Systems · Feb 1998
LEG'MAP OPTION
K973270 · Ge Medical Systems, Inc. · Nov 1997