Cleared Traditional

K083227 - VIDA PULMONARY WORKSTATION 2 (PW2)

K083227 is the FDA 510(k) clearance for VIDA PULMONARY WORKSTATION 2 (PW2) by Vida Diagnostics, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K083227 · Vida Diagnostics, Inc. · Radiology device
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Nov 2008
Decision
15d
Days
Class 2
Risk

K083227 is an FDA 510(k) clearance for the VIDA PULMONARY WORKSTATION 2 (PW2). Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Vida Diagnostics, Inc. (Iowa City, US). The FDA issued a Cleared decision on November 18, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Vida Diagnostics, Inc. devices

Submission Details

510(k) Number K083227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2008
Decision Date November 18, 2008
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
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 JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 582
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