Cleared Traditional

PRECISION RXI ANALOG X-RAY SYSTEM (K041605) - FDA 510(k) Clearance

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

K041605 · General Medical Merate S.P.A · Radiology device
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Jun 2004
Decision
15d
Days
Class 2
Risk

K041605 is an FDA 510(k) clearance for the PRECISION RXI ANALOG X-RAY SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by General Medical Merate S.P.A (Seriate (Bg), IT). The FDA issued a Cleared decision on June 30, 2004 after a review of 15 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 General Medical Merate S.P.A devices

Submission Details

510(k) Number K041605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date June 30, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 190
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K041605.
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K052412 · Ge Healthcare · Sep 2005
INNOVA 3100
K031637 · GE Medical Systems · Aug 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · Philips Medical Systems, Inc. · Jul 2003
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · Toshiba America Medical Systems, In.C · Nov 2001