# K230312: Iris AirShuttle™

- Pathway: 510(k) (Special)
- Applicant: Qfix
- Decided: Mar 31, 2023 after 56 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K121929 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160627: Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution, Qfix (2016) Summary page 5.

## Indications for use
Device-Specific Indications for Use/Intended Use: This device is intended for use as part of the AirDrive system to facilitate diagnostic and image guided procedures including under fluoroscopy, X-ray, CT, MR, other imaging procedures, and other procedures involving transfer of a patient. System Indications for Use/Intended Use: The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons or protons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Source page: https://510kreport.com/device/K230312
Methodology: https://510kreport.com/methodology