Cleared Traditional

K083048 - NEORAY DR 2520 DIGITAL IMAGING SYSTEM

K083048 is an FDA 510(k) clearance for NEORAY DR 2520 DIGITAL IMAGING SYSTEM, manufactured by Portavision Medical, LLC. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K083048 · Portavision Medical, LLC · Radiology device
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Nov 2008
Decision
38d
Days
Class 2
Risk

K083048 is an FDA 510(k) clearance for the NEORAY DR 2520 DIGITAL IMAGING SYSTEM. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Portavision Medical, LLC (Kenner, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Portavision Medical, LLC devices

FDA 510(k) Submission Details - K083048

510(k) Number K083048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date November 21, 2008
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 131
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K083048.
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K080945 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2008
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K072392 · Siemens Medical Solutions USA, Inc. · Sep 2007