Lumos 3DX
K-Number: K223780 · 2023-07-06
Applicant3Dio
Decision Date2023-07-06
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lumos 3DX is the device name listed in this FDA 510(k) record. The listed applicant is 3Dio. It received FDA 510(k) clearance on 2023-07-06 under 510(k) 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. The listed applicant is 3Dio. The 510(k) number is K223780.
When did Lumos 3DX receive FDA 510(k) clearance?
Lumos 3DX received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223780.
Who is the listed applicant for Lumos 3DX?
The FDA 510(k) record lists 3Dio as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lumos 3DX?
The FDA product code for Lumos 3DX is EHD.
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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.