10 CURIE IRDIUM 192, CSN00100-192— 510(k) K991571

Name: FDA 510(k) clearance K991571
Creator: U.S. Food and Drug Administration
Published: 2000-02-22

Substantially Equivalent

Alpha-Omega Services, Inc.

FDA 510(k) clearance K991571 for 10 CURIE IRDIUM 192, CSN00100-192, Substantially Equivalent on 2000-02-22. Applicant: Alpha-Omega Services, Inc.. Device class: 2.

Clearance details

Applicant: Alpha-Omega Services, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1999-05-05
Decision date: 2000-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXK

view all

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 Alpha-Omega Services, Inc.

view all

K233628 — AOS Interstitial Templates, Needles, and Accessories2024-07-10
K233626 — AOS Marker Seeds (SMG0242-025)2024-07-02
K102811 — AOS ORION IR-192 SOURCE CABLE2011-06-02
K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE2007-07-03
K062823 — AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES2007-05-29

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