Applicators for Varian Varisource Remote High Dose Rate Afterloader
FDA 510(k) K955844 · Varian Assoc., Inc.
510(k) numberK955844
Submission
- Device name
- Applicators for Varian Varisource Remote High Dose Rate Afterloader
- Applicant
- Varian Assoc., Inc.
Palo Alto, CA, US - Received
- December 26, 1995
- Decision date
- July 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAQ
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|---|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
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| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
| 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 |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K000922 | Proton VisionMUJ · Traditional | 05/24/2000SE |
| K992762 | Brachyvision 6.0MUJ · Traditional | 03/09/2000SE |
| K992751 | SomavisionKPQ · Traditional | 02/16/2000SE |
| K992753 | Cadplan Plus: 3D Treatment Planning SystemMUJ · Special | 09/03/1999SE |
| K990085 | Millennium MLC -120IYE · Special | 02/08/1999SE |
| K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…JAQ · Traditional | 10/21/1998SE |
| K955774 | Varis PortalvisionIYE · Traditional | 03/15/1996SE |
| K954467 | Cadplan BTJAQ · Traditional | 03/15/1996SE |
| K943224 | Varian Multileaf CollimatorIYE · Traditional | 02/02/1996SE |
| K952913 | Applicators for Varian Varisource Remote High Soes Rate AfterloaderJAQ · Traditional | 11/22/1995SE |
Questions and answers
When was Applicators for Varian Varisource Remote High Dose Rate Afterloader cleared by the FDA?
Applicators for Varian Varisource Remote High Dose Rate Afterloader (K955844) received a 510(k) decision of Substantially Equivalent on July 26, 1996, 213 days after the submission was received.
What is the product code of K955844?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.