Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Intracavitary/Interstitial System

K-Number: K250289 · 2025-04-25

ApplicantVarian Medical Systems
Decision Date2025-04-25
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Intracavitary/Interstitial System is a medical device manufactured by Varian Medical Systems. It received FDA 510(k) clearance on 2025-04-25 under approval number K250289. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intracavitary/Interstitial System?

Intracavitary/Interstitial System is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Varian Medical Systems. The 510(k) number is K250289.

When was Intracavitary/Interstitial System approved by the FDA?

Intracavitary/Interstitial System received FDA 510(k) clearance on 2025-04-25, under approval number K250289.

What company makes Intracavitary/Interstitial System?

Intracavitary/Interstitial System is manufactured by Varian Medical Systems.

What is the FDA product code for Intracavitary/Interstitial System?

The FDA product code for Intracavitary/Interstitial System is JAQ.

Related Clinical Trials

NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT06236516 One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors COMPLETED NCT06807359 Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED

Other Devices by Varian Medical Systems

K232400VariSeed (v10) K242378Eclipse Treatment Planning System (18.1) K242961Intraluminal Applicator Set K241965Catheter Surface Flap Applicator Set (GM11011830) K241876Vitesse (5.0) K252884Guided Aarhus Applicator Set

View all 8 devices →

Related Devices (Code: JAQ)

K160045Heyman Packing Applicator SetVarian Medical Systems, Inc. K161540Advanced Breast Template SystemVarian Medical Systems, Inc. K161576Esophagus Bougie SetVarian Medical Systems, Inc. K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengthsVarian Medical Systems, Inc. K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. K160021Varian Sterilization BoxesVarian Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑