Vscan
GUDID 00840682121651
GE Vingmed Ultrasound AS
General-purpose ultrasound imaging system| Primary Device ID | 00840682121651 |
| NIH Device Record Key | 976c5bcb-06e5-46de-bf09-8442f6553680 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vscan |
| Version Model Number | Extend |
| Company DUNS | 518870571 |
| Company Name | GE Vingmed Ultrasound AS |
| 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 |
Customer Support Contacts
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx | |
| Phone | +1(800)437-1171 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 62 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682121651 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161588
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-01 |
On-Brand Devices [Vscan]
| 00840682121651 | Extend |
| 00840682115384 | Gateway v.1.4 |
| 00840682107891 | Dual Probe |
| 00840682107853 | v1.2 |
| 00840682147484 | Vscan Air CL A1 |
| 00840682147101 | Vscan Air for Android |
| 00840682147071 | Vscan Air for iOS |
| 00195278660701 | Vscan Air SL |
| 00195278640574 | Vscan Air R2 Upgrade kit |
| 00195278640567 | Vscan Air R2 for Android |
| 00195278640550 | Vscan Air R2 for iOS |
Trademark Results [Vscan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VSCAN 85872562 4956193 Live/Registered |
Metrotech Corporation 2013-03-11 |
 VSCAN 77623773 3832602 Live/Registered |
General Electric Company 2008-12-01 |
 VSCAN 76277287 3060578 Dead/Cancelled |
I/O Controls Corporation 2001-06-26 |
 VSCAN 75394723 2304688 Dead/Cancelled |
Management Science Associates, Inc. 1997-11-24 |
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