| Primary Device ID | 00810035220539 |
| NIH Device Record Key | 73e149a5-8d8b-4dad-bb53-a3e39ff8ef5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuity DX+ |
| Version Model Number | 1 |
| Company DUNS | 005057263 |
| Company Name | RADMEDIX, LLC |
| 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 | true |
| 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 | 00810035220539 [Primary] |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
[00810035220539]
Liquid Chemical
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-21 |
| Device Publish Date | 2025-04-11 |
| 00810035220539 - Acuity DX+ | 2025-04-21 |
| 00810035220539 - Acuity DX+ | 2025-04-21 |
| 00810035220522 - Radmedix AcuityUDR | 2023-12-26 RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, gen |
| 00810035220492 - Radmedix AcuityDR 1717 G4 | 2023-07-28 AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography pan |
| 00810035220508 - Radmedix AcuityDR 1417 G4 | 2023-07-28 AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography pan |
| 00810035220515 - Radmedix AcuityDR 1013 G4 | 2023-07-28 AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography pan |
| 00810035220478 - Radmedix AcuityDRe 1417w | 2022-11-10 |
| 00810035220485 - Radmedix AcuityDRe 1717w | 2022-11-10 |
| 00810035220454 - Radmedix AcuityUDR | 2021-12-07 |