FDA 510(k)

BinkieRT

K-Number: K231852 · 2023-11-15

Decision Date2023-11-15

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BinkieRT is the device name listed in this FDA 510(k) record. The listed applicant is Papricalab. It received FDA 510(k) clearance on 2023-11-15 under 510(k) number K231852. 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 BinkieRT?

BinkieRT is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is Papricalab. The 510(k) number is K231852.

When did BinkieRT receive FDA 510(k) clearance?

BinkieRT received FDA 510(k) clearance on 2023-11-15, under 510(k) number K231852.

Who is the listed applicant for BinkieRT?

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

What is the FDA product code for BinkieRT?

The FDA product code for BinkieRT 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.