VIZION + DR— 510(k) K123644

Substantially Equivalent

Viztek, LLC

FDA 510(k) clearance K123644 for VIZION + DR, Substantially Equivalent on 2013-01-11. Applicant: Viztek, LLC. Device class: 2.

Clearance details

Applicant: Viztek, LLC
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2012-11-26
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Viztek, LLC

K160810 — ViZion DR + Wireless2016-05-20
K152279 — ViZion DR + Wireless2015-09-10
K142919 — EXA2014-12-16
K133139 — VIZION ULTRA2014-04-03
K112661 — VIZION DR2011-10-20

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