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FDA 510(k)

Iris AirShuttle™

K-Number: K230312 · 2023-03-31

ApplicantQfix
Decision Date2023-03-31
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Iris AirShuttle™ is the device name listed in this FDA 510(k) record. The listed applicant is Qfix. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K230312. 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 Iris AirShuttle™?

Iris AirShuttle™ is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Qfix. The 510(k) number is K230312.

When did Iris AirShuttle™ receive FDA 510(k) clearance?

Iris AirShuttle™ received FDA 510(k) clearance on 2023-03-31, under 510(k) number K230312.

Who is the listed applicant for Iris AirShuttle™?

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

What is the FDA product code for Iris AirShuttle™?

The FDA product code for Iris AirShuttle™ is IYE.

Other records listing Qfix 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.

K193243Alta Multipurpose DeviceK190668Encompass 15 Channel Head Coil, 3TK182189Encompass SRS Headframe ; Encompass MR SRS HeadframeK171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesK160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution

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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