FDA 510(k)

Pseudo-Patient

K-Number: K180697 · 2018-07-10

Decision Date2018-07-10

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Pseudo-Patient is the device name listed in this FDA 510(k) record. The listed applicant is Rtsafe, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180697. 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 Pseudo-Patient?

Pseudo-Patient is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Rtsafe, Inc.. The 510(k) number is K180697.

When did Pseudo-Patient receive FDA 510(k) clearance?

Pseudo-Patient received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180697.

Who is the listed applicant for Pseudo-Patient?

The FDA 510(k) record lists Rtsafe, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pseudo-Patient?

The FDA product code for Pseudo-Patient is IYE.

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 SA K253004LUNA 3DLap GmbH Laser Applikationen K260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC K252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla K253962ClearCheck (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.