| Primary Device ID | 07290018016077 |
| NIH Device Record Key | dc3eebe4-4581-49d2-b6fc-ae6e98242136 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HealthPNX |
| Version Model Number | 2.0.0 |
| Company DUNS | 600098228 |
| Company Name | NANO-X AI 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 | 07290018016077 [Primary] |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-03-28 |
| Device Publish Date | 2020-06-12 |
| 07290018016176 - HealthCCSng | 2025-02-27 - |
| 07290018016152 - HealthFLD | 2024-11-29 |
| 07290018016169 - HealthCCSng | 2024-11-29 |
| 07290018016145 - HealthOST | 2023-05-17 |
| 07290018016138 - HealthCCSng | 2023-05-12 |
| 07290018016114 - HealthOST | 2022-08-09 |
| 07290018016077 - HealthPNX | 2022-03-28 |
| 07290018016077 - HealthPNX | 2022-03-28 |