| Primary Device ID | 03760262651811 |
| NIH Device Record Key | d1797339-e761-49e6-8f90-04df980904ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Owandy Radiology |
| Version Model Number | I-Max 3D |
| Catalog Number | 9304100011 |
| Company DUNS | 265612235 |
| Company Name | OWANDY RADIOLOGY |
| 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 | true |
| 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 | 03760262651811 [Primary] |
| OAS | X-Ray, Tomography, Computed, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-12 |
| Device Publish Date | 2018-11-22 |
| 03760262652351 | Owandy- CR V2 Ethernet (REF.9458900031) |
| 03760262652337 | Owandy-CR V2 USB (REF.9458900021) |
| 03760262651811 | I-MAX 3D PAN ONLY 110-120V |
| 03760262651613 | I-MAX PAN ONLY 110-120V |
| 03760262651125 | OWANDY ONE SIZE 2 |
| 03760262651118 | OWANDY ONE SIZE 1 |
| 03760262651026 | Opteo size 2 |
| 03760262651019 | Opteo size 1 |
| 03760262650616 | Ow-RX |
| 03760262650210 | I-Max Touch 3D |
| 03760262650012 | I-Max Touch |