Cleared Traditional

K082243 - PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS

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
Combination Product No
PCCP Authorized No
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 318
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K082243.
VERADIUS, MODEL 718-130
K090590 · Philips Medical Systems North America Co. · Mar 2009
RADPRO ION
K083725 · Virtual Imaging, Inc. · Jan 2009
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
K081073 · Pausch, LLC · Dec 2008
RFVISION, MODEL 9.9D
K080847 · Almana Medical Imaging · Aug 2008
OEC 9900 ELITE
K073543 · Ge Oec Medical Systems · May 2008
AXIOM LUMINOS DRF
K062623 · Siemens Medical Solutions USA, Inc. · Aug 2007