Cleared Traditional

K150506 - ELIAN Digital Diagnostic X-ray System

K150506 is an FDA 510(k) clearance for ELIAN Digital Diagnostic X-ray System, manufactured by Osko, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K150506 · Osko, Inc. · Radiology device
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Apr 2015
Decision
41d
Days
Class 2
Risk

K150506 is an FDA 510(k) clearance for the ELIAN Digital Diagnostic X-ray System. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Osko, Inc. (Miami, US). The FDA issued a Cleared decision on April 8, 2015 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Osko, Inc. devices

FDA 510(k) Submission Details - K150506

510(k) Number K150506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2015
Decision Date April 08, 2015
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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

Mtechgroup
DAVE KIM

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 - KPR System, X-ray, Stationary

All 262
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