Lumos 3DX
K-Number: K223780 · 2023-07-06
Applicant3Dio
Decision Date2023-07-06
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lumos 3DX is a medical device manufactured by 3Dio. It received FDA 510(k) clearance on 2023-07-06 under approval number K223780. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lumos 3DX?
Lumos 3DX is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by 3Dio. The 510(k) number is K223780.
When was Lumos 3DX approved by the FDA?
Lumos 3DX received FDA 510(k) clearance on 2023-07-06, under approval number K223780.
What company makes Lumos 3DX?
Lumos 3DX is manufactured by 3Dio.
What is the FDA product code for Lumos 3DX?
The FDA product code for Lumos 3DX is EHD.
Related Devices (Code: EHD)
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.