INTEGRATED BRACHYTHERAPY UNIT - DIGITAL— 510(k) K072445

Name: FDA 510(k) clearance K072445
Creator: U.S. Food and Drug Administration
Published: 2007-09-14

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K072445 for INTEGRATED BRACHYTHERAPY UNIT - DIGITAL, Substantially Equivalent on 2007-09-14. Applicant: Nucletron Corp.. Device class: 2.

Clearance details

Applicant: Nucletron Corp.
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 2007-08-30
Decision date: 2007-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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