Cleared Traditional

XACT Robotic System (K191332) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence.

K191332 · Xact Robotics, Ltd. · Radiology device
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Oct 2019
Decision
140d
Days
Class 2
Risk

K191332 is an FDA 510(k) clearance for the XACT Robotic System. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Xact Robotics, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on October 3, 2019 after a review of 140 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 Xact Robotics, Ltd. devices

Submission Details

510(k) Number K191332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2019
Decision Date October 03, 2019
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan S. Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03008603 Completed Interventional Industry-sponsored

Evaluation of the Safety, Effectiveness & Usability of the XACT Robotic System for Image Guided Percutaneous Procedures

60
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied CT-guided Minimally Invasive Procedures e.g., Biopsies
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Xact Robotics Ltd. (industry)
Started 2018-09-04 → Primary completion 2021-02-16
Primary outcome
The primary endpoint of the study is to evaluate the clinical accuracy of the XACT system.
Secondary outcome
The secondary endpoint of the study is to evaluate the usability of the XACT system under actual use clinical conditions.
Study completed - no results published. This trial concluded in 2021 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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

All 421
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