Cleared Traditional

K161066 - SpotLight CT

K161066 is an FDA 510(k) clearance for SpotLight CT, manufactured by Arineta , Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K161066 · Arineta , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
117d
Days
Class 2
Risk

K161066 is an FDA 510(k) clearance for the SpotLight CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Arineta , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on August 10, 2016 after a review of 117 days - within the typical 510(k) review window.

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 Arineta , Ltd. devices

FDA 510(k) Submission Details - K161066

510(k) Number K161066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2016
Decision Date August 10, 2016
Days to Decision 117 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
10d slower than avg
Panel avg: 107d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT02616939 Unknown Observational

Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd

400
Patients (est.)
1
Site
Condition studied Coronary Artery Disease
Eligibility All sexes · 18 Years+
Principal investigator Ronen Rubinshtein, MD
Sponsor Carmel Medical Center
Started 2016-01-01 → Primary completion 2020-11-01 → Completed 2022-11-01
Primary outcome
Image quality (subjective) of the new SpotLight CT scanner from Arineta Ltd.
Secondary outcome
Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd.
View full study on ClinicalTrials.gov

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

All 767
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K161066.
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