ViZion DR + Wireless— 510(k) K152279

Substantially Equivalent

Viztek, LLC

FDA 510(k) clearance K152279 for ViZion DR + Wireless, Substantially Equivalent on 2015-09-10. 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: 2015-08-12
Decision date: 2015-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Garner, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Viztek, LLC

K160810 — ViZion DR + Wireless2016-05-20
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K133139 — VIZION ULTRA2014-04-03
K123644 — VIZION + DR2013-01-11
K112661 — VIZION DR2011-10-20

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