Cleared Traditional

VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET

K080934 · Nucletron Corporation · Radiology
May 2008
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K080934 is an FDA 510(k) clearance for the VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on May 28, 2008, 56 days after receiving the submission on April 2, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K080934 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2008
Decision Date May 28, 2008
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

Similar Devices — JAQ System, Applicator, Radionuclide, Remote-controlled

All 205
Rectal Applicator
K251037 · Nucletron B.V. · Dec 2025
Guided Aarhus Applicator Set
K252884 · Varian Medical Systems · Nov 2025
CT/ MR Tandem and Ovoid Set
K250299 · Varian Medical Systems, Inc. · May 2025
Intracavitary/Interstitial System
K250289 · Varian Medical Systems · Apr 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · Varian Medical Systems, Inc. · Mar 2025
Mould Probe MR Safe
K241764 · Varian Medical Systems, Inc. · Jan 2025