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FDA 510(k)

Beamscan MR

K-Number: K191646 · 2020-02-21

ApplicantPtw-Freiburg Physikalisch-Technische-Werkstaetten
Decision Date2020-02-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Beamscan MR is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191646. 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 Beamscan MR?

Beamscan MR is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten. The 510(k) number is K191646.

When did Beamscan MR receive FDA 510(k) clearance?

Beamscan MR received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191646.

Who is the listed applicant for Beamscan MR?

The FDA 510(k) record lists Ptw-Freiburg Physikalisch-Technische-Werkstaetten as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Beamscan MR?

The FDA product code for Beamscan MR is IYE.

Other records listing Ptw-Freiburg Physikalisch-Technische-Werkstaetten 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.

K213370VERIQAK160405OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D

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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