Cleared Traditional

K241764 - Mould Probe MR Safe (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241764 · Varian Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
204d
Days
Class 2
Risk

K241764 is an FDA 510(k) clearance for the Mould Probe MR Safe. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on January 10, 2025 after a review of 204 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K241764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2024
Decision Date January 10, 2025
Days to Decision 204 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
97d slower than avg
Panel avg: 107d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 205
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K241764.
Rectal Applicator
K251037 · Nucletron B.V. · Dec 2025
Guided Aarhus Applicator Set
K252884 · Varian Medical Systems · Nov 2025
CT/ MR Tandem and Ovoid Set
K250299 · Varian Medical Systems, Inc. · May 2025
Intracavitary/Interstitial System
K250289 · Varian Medical Systems · Apr 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · Varian Medical Systems, Inc. · Mar 2025
Intraluminal Applicator Set
K242961 · Varian Medical Systems · Nov 2024