GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM— 510(k) K983436

Name: FDA 510(k) clearance K983436
Creator: U.S. Food and Drug Administration
Published: 1998-10-29

Substantially Equivalent

Gammamed USA

FDA 510(k) clearance K983436 for GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM, Substantially Equivalent on 1998-10-29. Applicant: Gammamed USA. Device class: 2.

Clearance details

Applicant: Gammamed USA
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 1998-09-29
Decision date: 1998-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAQ

view all

K262383 — LumenCare Azure2026-07-24
K252717 — MAASTRO Rectal Applicator Set2026-05-20
K251037 — Rectal Applicator2025-12-19
K252884 — Guided Aarhus Applicator Set2025-11-19
K250299 — CT/ MR Tandem and Ovoid Set2025-05-09

Recalls naming K983436

K-number listed on FDA's recall record

Z-0607-2013 — Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.Class II·Terminated·Varian Medical Systems, Inc.·20120928

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983436.

Data sourced from openFDA. This site is unofficial and independent of the FDA.