Cleared Special

K173478 - OnSight 3D Extremity System

K173478 is an FDA 510(k) clearance for OnSight 3D Extremity System, manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 67-day FDA review.

K173478 · Carestream Health, Inc. · Radiology device
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Jan 2018
Decision
67d
Days
Class 2
Risk

K173478 is an FDA 510(k) clearance for the OnSight 3D Extremity System. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 67 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173478

510(k) Number K173478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date January 19, 2018
Days to Decision 67 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

JAK Device Classification - Class 2, Special Controls

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 826
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K173478 · OnSight 3D Extremity System
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