# K242395: Nanox.ARC

- Pathway: 510(k) (Traditional)
- Applicant: Nano-X Imaging, Ltd.
- Decided: Dec 4, 2024 after 113 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: 11 generations back to K803130 (1981). 40 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222934: Nanox.ARC, Nano-X Imaging, Ltd. (2023) Summary page 6.

## Most influential descendants
- K250850: Nanox.ARC X (2025), 1 descendant of its own
- K252649: TAP2D (2026), 0 descendants of its own

## Indications for use
Nanox.ARC is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients. This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicists. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions. This device is not intended for mammographic, angiographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.

Source page: https://510kreport.com/device/K242395
Methodology: https://510kreport.com/methodology