# K252133: Adaptix Ortho350

- Pathway: 510(k) (Traditional)
- Applicant: Adaptix Limited
- Decided: Nov 6, 2025 after 122 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862120 (1986). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221949: Ortho Device, ADAPTIX 3D Orthopedic Imaging System, Pausch Medical GmbH (2023) Summary page 5.

## Indications for use
The Adaptix Ortho350 is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained doctors or technicians on both adult and pediatric subjects. The Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of body extremities, upper/lower limbs, and adjacent anatomy in all routine radiography examinations. The device is not intended/indicated for use in imaging of the skull, chest, spinal column, hip, shoulder or in mammography applications.

Source page: https://510kreport.com/device/K252133
Methodology: https://510kreport.com/methodology