TAP2D
TAP2D is a cloud-based software accessory for the Nanox.ARC X and Nanox.ARC systems. It provides a supplemental enhanced 2D DICOM view from one projection in a tomosynthesis study, for…
TAP2D is a cloud-based software accessory for the Nanox.ARC X and Nanox.ARC systems.
It provides a supplemental enhanced 2D DICOM view from one projection in a tomosynthesis study, for assisting radiologists during evaluation.
Listed Item
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.
Supplemental Image Output
The image is tagged as a supplemental view and sent to PACS alongside the diagnostic tomosynthesis series, according to the device description. The module does not acquire images; it post-processes data acquired by the compatible system.
Who Else Makes It
All of them in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
Record
| Listed by | Nano-X Imaging Ltd, Israel |
|---|---|
| FDA product code | IZF |
| Device type | System, X-Ray, Tomographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1740 |
| Establishment | Manufacturer |
| 510(k) | K252649 |
| Record published | 2026-02-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nanox.ARC X | Nano-X Imaging Ltd | 1 |
| Discovery | Ge Hualun Medical Systems Co., Ltd. | 1 |
| Adaptix Ortho350 | Adaptix Limited | 1 |
| Nanox.ARC | Nano-X Imaging Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252649 | 2026-02-02 |
| K250850 | 2025-04-16 |
| K242395 | 2024-12-04 |
| K222934 | 2023-04-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.