iSMILE
K-Number: K200908 · 2020-12-22
Applicant3D Diagnostix, Inc.
Decision Date2020-12-22
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
iSMILE is a medical device manufactured by 3D Diagnostix, Inc.. It received FDA 510(k) clearance on 2020-12-22 under approval number K200908. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iSMILE?
iSMILE is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by 3D Diagnostix, Inc.. The 510(k) number is K200908.
When was iSMILE approved by the FDA?
iSMILE received FDA 510(k) clearance on 2020-12-22, under approval number K200908.
What company makes iSMILE?
iSMILE is manufactured by 3D Diagnostix, Inc..
What is the FDA product code for iSMILE?
The FDA product code for iSMILE is NXC.
Other Devices by 3D Diagnostix, Inc.
Related Devices (Code: NXC)
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.