IBU, INTEGRATED BRACHY THERAPY UNIT— 510(k) K973848

Name: FDA 510(k) clearance K973848
Creator: U.S. Food and Drug Administration
Published: 1998-01-22

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K973848 for IBU, INTEGRATED BRACHY THERAPY UNIT, Substantially Equivalent on 1998-01-22. 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: 1997-10-08
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPQ

view all

K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION2014-03-14
K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS2013-09-04
K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER2010-08-17
K090706 — ONCENTRA SIMULATION 2.32009-06-15
K083591 — IKOENGELO, VERSION 22008-12-29

More clearances from Nucletron Corp.

view all

K092804 — MICROSELECTRON HDR V2, MODEL 105.9992009-10-08
K091598 — LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS2009-06-29
K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL2007-09-14
K041715 — INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.0012005-03-24
K041933 — MICROSELECTRON PDR2004-08-18

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