Chrysalis Intelligence · Product Codes · JAQ

JAQ · System, Applicator, Radionuclide, Remote-Controlled

Radiology · 25 clearances · 6 unique sponsors

Device class
Class II
Regulation 892.5700
Total clearances
25
2020-02-28 → 2026-07-24
Last 12 months
4
Unique sponsors
6
Medical specialty
Radiology
Review panel
RA
Regulation number
892.5700
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Varian Medical Systems, Inc. 16 2 2026-05-20
Nucletron B.V. 3 2 2026-07-24
Mick Radio-Nuclear Instruments, Inc. 2 0 2023-08-30
Alpha-Omega Services, Inc. 2 0 2024-07-10
Geomed Medizin-Technik GmbH & Co. KG 1 0 2020-07-10
Braxx Biotech Co., Ltd. 1 0 2024-11-19
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
77790 CPT High Brachytherapy; remote-controlled radionuclide applicator systems for brachytherapy
77799 CPT Medium Unlisted radiotherapy procedure for specialized remote brachytherapy systems
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K262383 Nucletron B.V. LumenCare Azure
2026-05-20 K252717 Varian Medical Systems MAASTRO Rectal Applicator Set
2025-12-19 K251037 Nucletron B.V. Rectal Applicator
2025-11-19 K252884 Varian Medical Systems Guided Aarhus Applicator Set
2025-05-09 K250299 Varian Medical Systems, Inc. CT/ MR Tandem and Ovoid Set
2025-04-25 K250289 Varian Medical Systems Intracavitary/Interstitial System
2025-03-03 K243939 Varian Medical Systems, Inc. Titanium Flexible Geometry FSD Applicator Set (GM11013400)
2025-01-10 K241764 Varian Medical Systems, Inc. Mould Probe MR Safe
2024-11-26 K242961 Varian Medical Systems Intraluminal Applicator Set
2024-11-19 K243045 Braxx Biotech Co., Ltd. “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
2024-11-07 K241853 Varian Medical Systems, Inc. Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
2024-10-29 K241965 Varian Medical Systems Catheter Surface Flap Applicator Set (GM11011830)
2024-08-30 K241386 Varian Medical Systems, Inc. Heyman Packing Applicator Set (GM11004580)
2024-07-10 K233628 Alpha-Omega Services, Inc. AOS Interstitial Templates, Needles, and Accessories
2024-07-02 K233626 Alpha-Omega Services, Inc. AOS Marker Seeds (SMG0242-025)
2024-05-09 K240495 Varian Medical Systems, Inc. Flexible Fixation Device for Gynecological Applicators (GM11001960)
2024-04-09 K232623 Varian Medical Systems, Inc. Universal Endometrial Applicator Set (GM11009840)
2024-02-01 K232949 Varian Medical Systems, Inc. Kelowna GYN and Crook Prostate Templates
2023-08-30 K230155 Mick Radio-Nuclear Instruments, Inc. Mick Valencia Applicator Set
2023-03-13 K222775 Varian Medical Systems, Inc. Aarhus Applicator Set
2022-09-14 K221797 Varian Medical Systems, Inc. BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
2020-08-17 K193240 Varian Medical Systems, Inc. Universal Cylinder Applicator Family
2020-07-16 K201272 Nucletron B.V. Geneva
2020-07-10 K201279 Geomed Medizin-Technik GmbH & Co. KG ASSISTO Universal Applicator Clamping Device
2020-02-28 K200221 Mick Radio-Nuclear Instruments, Inc. 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 Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor