FDA.reportPublic FDA data

510(k) K232949

Device
Kelowna GYN and Crook Prostate Templates
Applicant
Varian Medical Systems, Inc.
510(k) number
K232949
Product code
JAQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-01
Date received
2023-09-20
Regulation
892.5700
Classification name
System, Applicator, Radionuclide, Remote-Controlled
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dr. Lynn Allman
Address
3100 Hansen Way Palo Alto CA US 94304 94304

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JAQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252717MAASTRO Rectal Applicator SetVarian Medical Systems2026-05-20
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K252884Guided Aarhus Applicator SetVarian Medical Systems2025-11-19
K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.2025-05-09
K250289Intracavitary/Interstitial SystemVarian Medical Systems2025-04-25
K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)Varian Medical Systems, Inc.2025-03-03
K241764Mould Probe MR SafeVarian Medical Systems, Inc.2025-01-10
K242961Intraluminal Applicator SetVarian Medical Systems2024-11-26
K243045“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)Braxx Biotech Co., Ltd.2024-11-19
K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveVarian Medical Systems, Inc.2024-11-07
K241965Catheter Surface Flap Applicator Set (GM11011830)Varian Medical Systems2024-10-29
K241386Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc.2024-08-30
K233628AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc.2024-07-10
K233626AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc.2024-07-02
K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)Varian Medical Systems, Inc.2024-05-09