Cleared Traditional

K120300 - CT-GUIDE NEEDLE GUIDANCE SYSTEM

K120300 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 73-day FDA review.

K120300 · Activiews, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
73d
Days
Class 2
Risk

K120300 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 April 13, 2012 after a review of 73 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. 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.

FDA 510(k) Submission Details - K120300

510(k) Number K120300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date April 13, 2012
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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
NCT01367392 Completed Interventional Industry-sponsored

Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System

Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System

20
Patients (actual)
1
Site
Open label
Masking
Condition studied Accurate Navigation to the Lesion
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor ActiViews Ltd. (industry)
Started 2011-06-01 → Primary completion 2012-01-01
Primary outcome
accuracy
Secondary outcome
time
Study completed - no results published. This trial concluded in 2012 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 K120300.
SOMATOM DEFINITION FLASH
K121072 · Siemens Medical Systems, Inc. · May 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
K113732 · Brainlab AG · May 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K113341 · Hitachi Medical Systems America, Inc. · May 2012
SYNGO CT DYNAMIC ANGIO
K120331 · Siemens AG Medical Solutions · Apr 2012
AQUILION CXL
K112989 · Toshiba America Medical Systems, In.C · Apr 2012
AQUILION ONE
K113466 · Toshiba Medical Systems Coporation, Japan · Apr 2012
K120300 · CT-GUIDE NEEDLE GUIDANCE SYSTEM
Download PDF FDA Summary Activiews, Ltd.