| Primary Device ID | 00854344007009 |
| NIH Device Record Key | 26c5b61b-7f3e-4754-8a9c-22f6f2f3df91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InfiMed Digital Imaging System, i5, DSA, CCD Camera |
| Version Model Number | i5 DSA |
| Company DUNS | 080506857 |
| Company Name | VAREX IMAGING CORPORATION |
| 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 | 00854344007009 [Primary] |
| OWB | Interventional Fluoroscopic X-Ray System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-24 |
| 00854344007764 - Varex Digital Imaging Software, Nexus DR, v4.17 | 2025-05-13 |
| 08718755003550 - Varex Imaging | 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |
| 08718755003574 - Varex Imaging | 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |
| 08718755003864 - Varex Imaging | 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |
| 08718755003871 - Varex Imaging | 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |
| 08718755003888 - Varex Imaging | 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |
| 08718755004021 - Varex Imaging | 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |
| 08718755003840 - Varex Imaging | 2025-03-04 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur |