GENETRA— 510(k) K013660

Substantially Equivalent

Radiomed Corporation

FDA 510(k) clearance K013660 for GENETRA, Substantially Equivalent on 2001-12-05. Applicant: Radiomed Corporation. Device class: 2.

Clearance details

Applicant: Radiomed Corporation
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2001-11-06
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Tyngsboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

K252296 — OncoPatch2025-12-05
K242818 — IsoSphere2025-07-15
K223465 — RadianceTx Radionuclide Brachytherapy Source2023-01-11
K221539 — GammaTile2022-11-09
K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2020-12-31

More clearances from Radiomed Corporation

K161724 — Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)2017-04-28
K120859 — PRE-LOADED GOLD VISICOIL CK MARKER2012-04-19
K070305 — PRE-LOADED VISICOIL2007-03-07
K022326 — RADIOMED MARKER2003-01-31

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