| Primary Device ID | 00817100020025 |
| NIH Device Record Key | 11e50237-1d60-4c30-9b10-9c556955feb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U-Arm System Basic |
| Version Model Number | XR3001 |
| Company DUNS | 080269345 |
| Company Name | KONICA MINOLTA MEDICAL IMAGING U.S.A., 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 |
| Phone | 1-800-366-5343 |
| HTICSupport@konicaminolta.com | |
| Phone | 1-800-366-5343 |
| HTICSupport@konicaminolta.com | |
| Phone | 1-800-366-5343 |
| HTICSupport@konicaminolta.com |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817100020025 [Primary] |
| KPR | System, X-Ray, Stationary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00817100020254 - 14X17 Wireless GOS Flat Panel Detector | 2019-05-07 IR 14X17 Wireless GOS Flat Panel Detector -R or -L) |
| 00817100020315 - RF 14X17 Sensor Panel | 2019-05-07 RF 14X17 Sensor Panel-R |
| 00817100020483 - RF 11X14 Sensor Panel | 2019-05-07 RF 11X14 Sensor Panel -R/-L |
| 00817100020513 - RF 11X14 Sensor Panel | 2019-05-07 DR-PANEL-LT1114-L / R |
| 00817100020193 - Konica Minolta SW (PACS) Exa | 2019-02-21 EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound s |
| 00817100020209 - Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad | 2019-02-21 Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultraso |
| 00817100020216 - 17X17 CsI Fixed Flat Panel Detector | 2019-02-21 IR 17X17 CsI Fixed Flat Panel Detector (-R or -L) |
| 00817100020223 - 17X17 GOS Fixed Flat Panel Detector | 2019-02-21 IR 17X17 GOS Fixed Flat Panel Detector (-R or -L) |