Evolution4K
GUDID 00817613020468
LCD touch screen recording system with HDMI loop through
MED X CHANGE, INC.
Endoscopic video image processing unit| Primary Device ID | 00817613020468 |
| NIH Device Record Key | 146742cc-b51b-4a28-91d1-bb38878ce294 |
| Commercial Distribution Discontinuation | 2018-10-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Evolution4K |
| Version Model Number | Evo4K100 |
| Company DUNS | 051244569 |
| Company Name | MED X CHANGE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817613020468 [Primary] |
FDA Product Code
| LMB | Device, Digital Image Storage, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2018-05-07 |
On-Brand Devices [Evolution4K]
| 00817613020659 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020642 | LCD touch screen recording system with HDMI loop through |
| 00817613020628 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613020598 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020581 | LCD touch screen recording system with HDMI loop through |
| 00817613020574 | LCD touch screen recording system with HDMI loop through |
| 00817613020567 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020468 | LCD touch screen recording system with HDMI loop through |
| 00817613020451 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020406 | LCD touch screen recording system with HDMI loop through |
| 00817613020390 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020314 | LCD touch screen recording system with HDMI loop through |
| 00817613020710 | LCD touch screen recording system with HDMI loop through |
| 00817613020772 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613020727 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613020864 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020734 | LCD touch screen recording system with HDMI loop through |
| 00817613020895 | LCD touch screen recording system with HDMI loop through |
| 00817613020741 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020857 | LCD touch screen recording system with HDMI loop through. Software version update 1.7.14 |
| 00817613020994 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613020956 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020949 | LCD touch screen recording system with HDMI loop through |
| 00817613021090 | LCD touch screen recording system with HDMI loop through. Software version 1.7.25 |
| 00817613020970 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version Software Upgrade from version 1.6.2 to 1. |
| 00817613021113 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613021014 | LCD touch screen recording system with HDMI loop through |
| 00817613021137 | LCD touch screen recording system with HDMI loop through. Software version 1.7.28 |
| 00817613021205 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613021199 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613021182 | LCD touch screen recording system with HDMI loop through |
| 00817613021168 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613021236 | LCD touch screen recording system with HDMI loop through |
| 00817613021229 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613021328 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613020222 | LCD touch screen recording system with HDMI loop through. |
| 00817613020185 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
| 00817613020178 | Evolution4K Recording System - Quad SDI Version, LCD touch screen recording system |
| 00817613020086 | LCD touch screen recording system with HDMI loop through |
| 00817613020062 | Evolution4K Recording System - HDMI 2.0/3G-SDI Version |
Trademark Results [Evolution4K]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVOLUTION4K 87338184 5419650 Live/Registered |
Med X Change, Inc. 2017-02-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.