510(k) K120344
- Device
- RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
- Applicant
- RADIADYNE, LLC (SPECIFICATION DEVELOPER)
- 510(k) number
- K120344
- Product code
- JAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-05-03
- Date received
- 2012-02-03
- 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
- STUART R GOLDMAN
- Address
- 11931 Wickchester Ln. Houston TX US 77043 77043
FDA Registration Numbers#
- 1222780
- 2184007
- 3010813819
- 2029275
- 3007200016
- 1181121
- 2022435
- 3016602874
- 1220477
- 2032338
- 3015309643
- 3006950086
- 2246552
- 9610348
- 2022694
- 3033589330
- 1422634
- 3000270450
- 3009417901
- 8010168
- 3003660614
- 3004111573
- 1219183
- 2021969
- 3008236846
- 1644312
- 3015232217
- 2518443
- 2032112
- 1649518
- 3004784537
- 3034286426
- 3038188187
- 3014246639
- 3015225571
- 3032638959
- 3011106828
- 3019543601
- 3012536737
- 1120804
- 1417485
- 1000523114
- 9611894
- 2431392
- 1650907
Source Documents#
Other 510(k) Records For Product Code JAQ #
| 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 |
Legacy Summary#
summary
FDA Review#
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