Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source— 510(k) K162573

Name: FDA 510(k) clearance K162573
Creator: U.S. Food and Drug Administration
Published: 2016-11-04

Substantially Equivalent

Source Production and Equipment Co., Inc.

FDA 510(k) clearance K162573 for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source, Substantially Equivalent on 2016-11-04. Applicant: Source Production and Equipment Co., Inc.. Device class: 2.

Clearance details

Applicant: Source Production and Equipment Co., Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2016-09-15
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Rose, LA, 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 Source Production and Equipment Co., Inc.

view all

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