Cleared Traditional

K090590 - VERADIUS

K090590 is an FDA 510(k) clearance for VERADIUS, manufactured by Philips Medical Systems North America Co.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K090590 · Philips Medical Systems North America Co. · Radiology device
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Mar 2009
Decision
12d
Days
Class 2
Risk

K090590 is an FDA 510(k) clearance for the VERADIUS, MODEL 718-130. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on March 16, 2009 after a review of 12 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 Philips Medical Systems North America Co. devices

FDA 510(k) Submission Details - K090590

510(k) Number K090590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2009
Decision Date March 16, 2009
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 245
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K090590.
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K061163 · Ge Medical Systems, LLC · Jun 2006