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FDA 510(k)

Image Guidance System for Radiotherapy

K-Number: K192405 · 2020-05-01

ApplicantJiangsu Rayer Medical Technology Co., Ltd.
Decision Date2020-05-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Image Guidance System for Radiotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rayer Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192405. 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 Image Guidance System for Radiotherapy?

Image Guidance System for Radiotherapy is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Jiangsu Rayer Medical Technology Co., Ltd.. The 510(k) number is K192405.

When did Image Guidance System for Radiotherapy receive FDA 510(k) clearance?

Image Guidance System for Radiotherapy received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192405.

Who is the listed applicant for Image Guidance System for Radiotherapy?

The FDA 510(k) record lists Jiangsu Rayer Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Guidance System for Radiotherapy?

The FDA product code for Image Guidance System for Radiotherapy is IYE.

Related Clinical Trials

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.

NCT04086082Markerless Image Guidance Using Intrafraction Kilovoltage X-ray ImagingRECRUITINGNCT05176860Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision RadiotherapyCOMPLETED

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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