Cleared Traditional

K082243 - PRECISION RXI ANALOG AND DIGITAL X-RAY ...

K082243 is an FDA 510(k) clearance for PRECISION RXI ANALOG AND DIGITAL X-RAY ..., manufactured by General Medical Merate S.P.A. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K082243 · General Medical Merate S.P.A · Radiology device
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Nov 2008
Decision
92d
Days
Class 2
Risk

K082243 is an FDA 510(k) clearance for the PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by General Medical Merate S.P.A (Greenwood Village, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 92 days - within the typical 510(k) review window.

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: 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 General Medical Merate S.P.A devices

FDA 510(k) Submission Details - K082243

510(k) Number K082243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2008
Decision Date November 07, 2008
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

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 246
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K082243.
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
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AXIOM LUMINOS DRF
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INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
K061163 · Ge Medical Systems, LLC · Jun 2006