Gammamed Plus High Dose Rate Remote Afterloading System
FDA 510(k) K983436 · Gammamed USA
510(k) numberK983436
Submission
- Device name
- Gammamed Plus High Dose Rate Remote Afterloading System
- Applicant
- Gammamed USA
Ann Arbor, MI, US - Received
- September 29, 1998
- Decision date
- October 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | Varian Medical Systems | 05/20/2026SE |
| 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 |
Questions and answers
When was Gammamed Plus High Dose Rate Remote Afterloading System cleared by the FDA?
Gammamed Plus High Dose Rate Remote Afterloading System (K983436) received a 510(k) decision of Substantially Equivalent on October 29, 1998, 30 days after the submission was received.
What is the product code of K983436?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.