I-MAX TOUCH 3D— 510(k) K130443

Substantially Equivalent

Owandy

FDA 510(k) clearance K130443 for I-MAX TOUCH 3D, Substantially Equivalent on 2013-06-14. Applicant: Owandy. Device class: 2.

Clearance details

Applicant: Owandy
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2013-02-21
Decision date: 2013-06-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Owandy

K133271 — OPTEO, VIDEOGRAPH HD2014-04-28
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Recalls naming K130443

K-number listed on FDA's recall record

Z-0129-2016 — Owandy Radiology I -MAX Touch 3D X-rayClass II·Terminated·Villa Radiology Systems LLC·20150805

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130443.

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