# K252649: TAP2D

- Pathway: 510(k) (Traditional)
- Applicant: Nano-X Imaging, Ltd.
- Decided: Feb 2, 2026 after 165 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: 13 generations back to K803130 (1981). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250850: Nanox.ARC X, Nano-X Imaging, Ltd. (2025) Summary page 5.

## Indications for use
TAP2D is a cloud-based software-module accessory intended exclusively for use with the Nanox.ARC X and Nanox.ARC systems, consistent with their cleared indications for use. TAP2D is intended to provide a supplemental processed and enhanced 2D view image in DICOM format of a single 2D projection extracted from the acquired DTS study. TAP2D is specifically indicated for assisting radiologists when evaluating diagnostic tomosynthesis studies and reaching their own diagnosis.

Source page: https://510kreport.com/device/K252649
Methodology: https://510kreport.com/methodology