Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DORADOnova MR3T

K-Number: K173926 · 2018-09-14

ApplicantLap GmbH Laser Applikationen
Decision Date2018-09-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DORADOnova MR3T is a medical device manufactured by Lap GmbH Laser Applikationen. It received FDA 510(k) clearance on 2018-09-14 under approval number K173926. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORADOnova MR3T?

DORADOnova MR3T is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Lap GmbH Laser Applikationen. The 510(k) number is K173926.

When was DORADOnova MR3T approved by the FDA?

DORADOnova MR3T received FDA 510(k) clearance on 2018-09-14, under approval number K173926.

What company makes DORADOnova MR3T?

DORADOnova MR3T is manufactured by Lap GmbH Laser Applikationen.

What is the FDA product code for DORADOnova MR3T?

The FDA product code for DORADOnova MR3T is IYE.

Other Devices by Lap GmbH Laser Applikationen

K200907Thales 3D Mr Scanner K232031LUNA 3D

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

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.

↑