| Primary Device ID | 07290018465066 |
| NIH Device Record Key | 38361133-daae-472c-a982-765ba3a3641c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TAP2D |
| Version Model Number | 1.0 |
| Company DUNS | 521092973 |
| Company Name | NANO-X IMAGING LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290018465066 [Primary] |
| IZF | System, X-Ray, Tomographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-26 |
| Device Publish Date | 2026-02-18 |
| 07290018465066 - TAP2D | 2026-02-26TAP2D 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. |
| 07290018465066 - TAP2D | 2026-02-26 TAP2D is a cloud-based software-module accessory intended exclusively for use with the Nanox.ARC X and Nanox.ARC systems, consis |
| 07290018465011 - Nanox.ARC X | 2025-09-12 |
| 07290018465004 - Nanox.ARC | 2023-11-03 |