Cleared Traditional

K002198 - FLUOROSCAN PROFILE, MODEL TCA 4 PLUS (FDA 510(k) Clearance)

Also includes:
FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002198 · Fluoro Scan Imaging Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
89d
Days
Class 2
Risk

K002198 is an FDA 510(k) clearance for the FLUOROSCAN PROFILE, MODEL TCA 4 PLUS. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Fluoro Scan Imaging Systems, Inc. (Northbrook, US). The FDA issued a Cleared decision on October 17, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Fluoro Scan Imaging Systems, Inc. devices

Submission Details

510(k) Number K002198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date October 17, 2000
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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.

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