Product code JAQ

Device name: System, Applicator, Radionuclide, Remote-Controlled
Medical specialty: Radiology
Device class: 2
Regulation number: 892.5700
Review panel: RA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K252717	MAASTRO Rectal Applicator Set	Varian Medical Systems	2026-05-20
K251037	Rectal Applicator	Nucletron B.V.	2025-12-19
K252884	Guided Aarhus Applicator Set	Varian Medical Systems	2025-11-19
K250299	CT/ MR Tandem and Ovoid Set	Varian Medical Systems, Inc.	2025-05-09
K250289	Intracavitary/Interstitial System	Varian Medical Systems	2025-04-25
K243939	Titanium Flexible Geometry FSD Applicator Set (GM11013400)	Varian Medical Systems, Inc.	2025-03-03
K241764	Mould Probe MR Safe	Varian Medical Systems, Inc.	2025-01-10
K242961	Intraluminal Applicator Set	Varian Medical Systems	2024-11-26
K243045	“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)	Braxx Biotech Co., Ltd.	2024-11-19
K241853	Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve	Varian Medical Systems, Inc.	2024-11-07
K241965	Catheter Surface Flap Applicator Set (GM11011830)	Varian Medical Systems	2024-10-29
K241386	Heyman Packing Applicator Set (GM11004580)	Varian Medical Systems, Inc.	2024-08-30
K233628	AOS Interstitial Templates, Needles, and Accessories	Alpha-Omega Services, Inc.	2024-07-10
K233626	AOS Marker Seeds (SMG0242-025)	Alpha-Omega Services, Inc.	2024-07-02
K240495	Flexible Fixation Device for Gynecological Applicators (GM11001960)	Varian Medical Systems, Inc.	2024-05-09
K232623	Universal Endometrial Applicator Set (GM11009840)	Varian Medical Systems, Inc.	2024-04-09
K232949	Kelowna GYN and Crook Prostate Templates	Varian Medical Systems, Inc.	2024-02-01
K230155	Mick Valencia Applicator Set	Mick Radio-Nuclear Instruments, Inc.	2023-08-30
K222775	Aarhus Applicator Set	Varian Medical Systems, Inc.	2023-03-13
K221797	BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device	Varian Medical Systems, Inc.	2022-09-14
K193240	Universal Cylinder Applicator Family	Varian Medical Systems, Inc.	2020-08-17
K201272	Geneva	Nucletron B.V.	2020-07-16
K201279	ASSISTO Universal Applicator Clamping Device	Geomed Medizin-Technik GmbH & Co. KG	2020-07-10
K200221	CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial...	Mick Radio-Nuclear Instruments, Inc.	2020-02-28
K191580	BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device	Varian Medical Systems, Inc.	2019-07-08
K183332	“BRAXX” Esophageal Brachytherapy Applicator	Braxx Biotech Co., Ltd.	2019-04-16
K172533	GM Implant Tubes, Length Cutting Gauge	Varian Medical Systems, Inc.	2018-10-22
K181903	BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device	Varian Medical Systems, Inc.	2018-10-03
K172675	Varian Cervical Sleeves	Varian Medical Systems, Inc.	2018-05-16
K180069	HDR MRI Lumen Marker	C4 Imaging, LLC	2018-04-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08717213007826	Fletcher Williamson Applicator	Nucletron B.V.	2018-07-06
08717213007796	Fletcher Williamson Applicator	Nucletron B.V.	2018-07-06
08717213007772	Fletcher Williamson Applicator	Nucletron B.V.	2018-07-06
08717213007765	Esophageal Applicator	Nucletron B.V.	2018-06-20
08717213007017	Interstitial needles	Nucletron B.V.	2016-12-02
08717213007413	Interstitial needles	Nucletron B.V.	2016-12-02
08717213007512	MUPIT Applicator	Nucletron B.V.	2016-12-02
08717213007598	Interstitial needles	Nucletron B.V.	2016-12-02
08717213001145	MicroSelectron Digital	Nucletron B.V.	2016-11-30
08717213002999	Pipard Tongue Template	Nucletron B.V.	2016-11-30
08717213000940	MicroSelectron Digital	Nucletron B.V.	2016-11-30
08717213007758	Esophageal Applicator	Nucletron B.V.	2016-11-25
08717213007147	NA	Nucletron B.V.	2016-10-07
08717213003453	Henschke Titanium Applicator	Nucletron B.V.	2016-09-17
08717213007871	Fletcher Williamson Applicator	Nucletron B.V.	2016-09-10
08717213007888	Fletcher Williamson Applicator	Nucletron B.V.	2016-09-10
08717213007895	Fletcher Williamson Applicator	Nucletron B.V.	2016-09-10
08717213003446	Henschke Titanium Applicator	Nucletron B.V.	2016-09-10
08717213002074	Breast Template Set	Nucletron B.V.	2016-09-10
08717213002050	Breast Template Set	Nucletron B.V.	2016-09-10
08717213002043	Breast Template Set	Nucletron B.V.	2016-09-10
08717213002036	Breast Template Set	Nucletron B.V.	2016-09-10
08717213002029	Breast Template Set	Nucletron B.V.	2016-09-10
08717213002012	Breast Template Set	Nucletron B.V.	2016-09-10
08717213002005	Breast Template Set	Nucletron B.V.	2016-09-10
08717213001992	Breast Template Set	Nucletron B.V.	2016-09-10
08717213001985	Breast Template Set	Nucletron B.V.	2016-09-10
08717213001978	Breast Template Set	Nucletron B.V.	2016-09-10
08717213001961	Breast Template Set	Nucletron B.V.	2016-09-10
08717213001954	Breast Template Set	Nucletron B.V.	2016-09-10

Product code JAQ

Related 510(k) Records#

Related GUDID Devices#