Vienna System
FDA 510(k) K142597 · Mick Radio-Nuclear Instruments, Inc.
510(k) numberK142597
Submission
- Device name
- Vienna System
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
Mt. Vernon, NY, US - Received
- September 15, 2014
- Decision date
- February 19, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
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| K250299 | CT/ MR Tandem and Ovoid SetJAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2025SE |
| K250289 | Intracavitary/Interstitial SystemJAQ · Traditional | Varian Medical Systems | 04/25/2025SE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional | Varian Medical Systems, Inc. | 03/03/2025SE |
| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
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More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K230155 | Mick Valencia Applicator SetJAQ · Traditional | 08/30/2023SE |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…JAQ · Special | 02/28/2020SE |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN TemplateJAQ · Traditional | 05/31/2016SE |
| K122840 | CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407JAQ · Traditional | 12/14/2012SE |
| K063382 | HDR CT Compatible Split Ring ApplicatorJAQ · Traditional | 12/26/2006SE |
| K063381 | CT Compatible F/S/D ApplicatorsJAQ · Traditional | 12/22/2006SE |
| K052351 | HDR Iort Shielded ApplicatorJAQ · Traditional | 10/17/2005SE |
| K051423 | Mick HDR Interstitial Implant AccessoriesJAQ · Traditional | 07/01/2005SE |
| K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorJAQ · Traditional | 06/18/2004SE |
| K033828 | CT Compatible Intrauterine Sleeves, Cat #0311, 9406JAQ · Traditional | 02/02/2004SE |
Questions and answers
When was Vienna System cleared by the FDA?
Vienna System (K142597) received a 510(k) decision of Substantially Equivalent on February 19, 2015, 157 days after the submission was received.
What is the product code of K142597?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.