Cleared Traditional

K150663 - Diagnostic X-ray System

K150663 is the FDA 510(k) clearance for Diagnostic X-ray System by Osko, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K150663 · Osko, Inc. · Radiology device
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May 2015
Decision
52d
Days
Class 2
Risk

K150663 is an FDA 510(k) clearance for the 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 May 7, 2015 after a review of 52 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

Submission Details

510(k) Number K150663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2015
Decision Date May 07, 2015
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - KPR System, X-ray, Stationary

All 165
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K150663.
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GC85A
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DRX-EVOLUTION
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