Cleared Traditional

K110812 - CT-GUIDE NEEDLE GUIDANCE SYSTEM

K110812 is an FDA 510(k) clearance for CT-GUIDE NEEDLE GUIDANCE SYSTEM, manufactured by Activiews, Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K110812 · Activiews, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
90d
Days
Class 2
Risk

K110812 is an FDA 510(k) clearance for the CT-GUIDE NEEDLE GUIDANCE SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Activiews, Ltd. (Washington, US). The FDA issued a Cleared decision on June 21, 2011 after a review of 90 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.

FDA 510(k) Submission Details - K110812

510(k) Number K110812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2011
Decision Date June 21, 2011
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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
NCT01183182 Completed Interventional Industry-sponsored

Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies

Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System

48
Patients (actual)
3
Sites
Open label
Masking
Condition studied Lung Diseases
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Paul Narinder, MD
Sponsor ActiViews Ltd. (industry)
Started 2010-08-01 → Primary completion 2011-02-01 → Completed 2011-03-01
Primary outcome
Number of patients with successful targeting accuracy as defined by the frequency of placing the needle at a location suitable for obtaining tissue sample from the target lesion.
Secondary outcome
Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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

All 798
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K110812.
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K093581 · Ge Medical Systems, LLC · Apr 2011
SYNGO.CT CARDIAC FUNCTION
K110366 · Siemens AG · Apr 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888 · Hitachi Medical Systems America, Inc. · Apr 2011
K110812 · CT-GUIDE NEEDLE GUIDANCE SYSTEM
Download PDF FDA Summary Activiews, Ltd.