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)

Thales 3D Mr Scanner

K-Number: K200907 · 2020-06-03

ApplicantLap GmbH Laser Applikationen
Decision Date2020-06-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Thales 3D Mr Scanner is a medical device manufactured by Lap GmbH Laser Applikationen. It received FDA 510(k) clearance on 2020-06-03 under approval number K200907. 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 Thales 3D Mr Scanner?

Thales 3D Mr Scanner is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Lap GmbH Laser Applikationen. The 510(k) number is K200907.

When was Thales 3D Mr Scanner approved by the FDA?

Thales 3D Mr Scanner received FDA 510(k) clearance on 2020-06-03, under approval number K200907.

What company makes Thales 3D Mr Scanner?

Thales 3D Mr Scanner is manufactured by Lap GmbH Laser Applikationen.

What is the FDA product code for Thales 3D Mr Scanner?

The FDA product code for Thales 3D Mr Scanner is IYE.

Other Devices by Lap GmbH Laser Applikationen

K173926DORADOnova MR3T 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.

↑