Cleared Traditional

K160723 - OnSight 3D Extremity System

K160723 is the FDA 510(k) clearance for OnSight 3D Extremity System by Carestream Health, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K160723 · Carestream Health, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
167d
Days
Class 2
Risk

K160723 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 August 30, 2016 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carestream Health, Inc. devices

Submission Details

510(k) Number K160723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2016
Decision Date August 30, 2016
Days to Decision 167 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
60d slower than avg
Panel avg: 107d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02445287 Completed Interventional Industry-sponsored

Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)

48
Patients (actual)
Diagnostic
Purpose
Single blind
Masking
Condition studied Healthy
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator John Marzo, MD
Sponsor Carestream Health, Inc. (industry)
Started 2015-09-01 → Primary completion 2015-11-01
Primary outcome
Radlex Scale for Diagnostic Quality Ratings - 2D Images
View full study on ClinicalTrials.gov

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 593
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K160723.
Somatom Confidence ® RT Pro
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Revolution CT
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Vitrea CT Dual Energy Image View
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SOMATOM Drive
K161196 · Siemens Medical Solutions USA, Inc. · Aug 2016
SUPRIA w/guideShot Option
K161748 · Hitachi Medical Systems America, Inc. · Aug 2016
Philips Ingenuity CT
K160743 · Philips Medical Systems (Cleveland), Inc. · Aug 2016