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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 the device name listed in this FDA 510(k) record. The listed applicant is Lap GmbH Laser Applikationen. It received FDA 510(k) clearance on 2020-06-03 under 510(k) 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. The listed applicant is Lap GmbH Laser Applikationen. The 510(k) number is K200907.

When did Thales 3D Mr Scanner receive FDA 510(k) clearance?

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

Who is the listed applicant for Thales 3D Mr Scanner?

The FDA 510(k) record lists Lap GmbH Laser Applikationen as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Lap GmbH Laser Applikationen as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253004LUNA 3DK232031LUNA 3DK173926DORADOnova MR3T

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

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.

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