| Primary Device ID | 00810035220515 |
| NIH Device Record Key | 22e13888-740e-4756-9276-03ee20cdafcb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radmedix AcuityDR 1013 G4 |
| 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 | 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 | 00810035220515 [Primary] |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
[00810035220515]
Liquid Chemical
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-28 |
| Device Publish Date | 2023-07-20 |
| 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 | 2023-07-28AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919. |
| 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 |
| 00810035220461 - Radmedix AcuityPDR+ | 2021-12-07 |