Cleared Traditional

K260510 - VenusCT

K260510 is an FDA 510(k) clearance for VenusCT, manufactured by Linatech, LLC. The device is a Class 2 Radiology device with product code SFV cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K260510 · Linatech, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
244d
Days
Class 2
Risk

K260510 is an FDA 510(k) clearance for the VenusCT. Classified as X-ray, Computed Tomography, Cone-beam (product code SFV), Class II - Special Controls.

Submitted by Linatech, LLC (Sunnyvale, US). The FDA issued a Cleared decision on October 19, 2026 after a review of 244 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.

FDA 510(k) Submission Details - K260510

510(k) Number K260510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2026
Decision Date October 19, 2026
Days to Decision 244 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
137d slower than avg
Panel avg: 107d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SFV Device Classification - Class 2, Special Controls

Product Code SFV X-ray, Computed Tomography, Cone-beam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Cone-beam Computed Tomography Produced Cross-sectional Diagnostic X-ray Images Of Whole Body Except Dental Structures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

K260510 · VenusCT
Download PDF FDA Summary Linatech, LLC