| Primary Device ID | 00850044606054 |
| NIH Device Record Key | 8c7dfffe-f367-41ea-9e1d-8fd85d8687e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XR90 |
| Version Model Number | XR90-SYS |
| Company DUNS | 117407269 |
| Company Name | Mediview Xr, Inc. |
| 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 | 00850044606054 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-31 |
| Device Publish Date | 2023-10-23 |
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| 00860006066369 - XR90 System, LOGIQ | 2025-01-10 |
| 00860006066376 - XR90 System, LOGIQ, Single Headset | 2025-01-10 |
| 00860006066383 - XR90 System, LOGIQ, Upgrade Kit | 2025-01-10 |
| 00850044606061 - OmnifyXR | 2023-11-09 The OmnifyXR is an adjunctive augmented reality display to interventional x-ray imaging systems. The system is comprised of a co |
| 00850044606009 - Triangle Template Kit | 2023-11-01 MediView Triangle Template Kit for use with the XR90 system. |
| 10850044606013 - Registration Marker Kit, Sterile, Single | 2023-10-31 MediView single sterile Registration Marker kit for use with XR90. |
| 00850044606023 - EM Probe Bracket Kit, C1-5, Single | 2023-10-31 MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers. |