SuniIQ Digital Radiography System
K-Number: K162585 · 2016-11-04
ApplicantSuni Medical Imaging, Inc.
Decision Date2016-11-04
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SuniIQ Digital Radiography System is a medical device manufactured by Suni Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K162585. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SuniIQ Digital Radiography System?
SuniIQ Digital Radiography System is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Suni Medical Imaging, Inc.. The 510(k) number is K162585.
When was SuniIQ Digital Radiography System approved by the FDA?
SuniIQ Digital Radiography System received FDA 510(k) clearance on 2016-11-04, under approval number K162585.
What company makes SuniIQ Digital Radiography System?
SuniIQ Digital Radiography System is manufactured by Suni Medical Imaging, Inc..
What is the FDA product code for SuniIQ Digital Radiography System?
The FDA product code for SuniIQ Digital Radiography System is MUH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.