510(k) K172611
- Device
- Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, Odd Lengths And Even Lengths, Universal Titanium Cervix Probe Sets, Odd Lengths And Even Lengths
- Applicant
- Varian Medical Systems, Inc
- 510(k) number
- K172611
- Product code
- JAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-21
- Date received
- 2017-08-31
- Regulation
- 892.5700
- Classification name
- System, Applicator, Radionuclide, Remote-controlled
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Peter J. Coronado
- Address
- 911 Hansen Way Palo Alto CA US 94304 94304
FDA Registration Numbers#
- 2032338
- 1650907
- 9611894
- 3006950086
- 1220477
- 1120804
- 3004784537
- 3008236846
- 8010168
- 3033589330
- 3015232217
- 3011106828
- 3032638959
- 1649518
- 3000270450
- 2022435
- 3019543601
- 9610348
- 1721504
- 1181121
- 2032112
- 3038188187
- 2029275
- 1222780
- 2021969
- 3010813819
- 1417485
- 2246552
- 2431392
- 3012536737
- 3007200016
- 3015225571
- 3009417901
- 2184007
- 3016602874
- 1644312
- 1000523114
- 2022694
- 3014246639
- 3004111573
- 3034286426
- 2518443
- 3015309643
- 1219183
- 1422634
- 3003660614
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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