LOGIQ 5946725
GUDID 00195278835741
LOGIQ Fortis R3 to R4 SW Upgrade
GE Ultrasound Korea Ltd.
General-purpose ultrasound imaging system| Primary Device ID | 00195278835741 |
| NIH Device Record Key | 24ad8301-6b2d-42bf-9b41-6353c2d9b820 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOGIQ |
| Version Model Number | Fortis R3 to R4 SW Upgrade |
| Catalog Number | 5946725 |
| Company DUNS | 690168810 |
| Company Name | GE Ultrasound Korea Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195278835741 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231989
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-13 |
| Device Publish Date | 2024-03-05 |
On-Brand Devices [LOGIQ]
| 00840682144254 | S8 R4 to R4.5 UPG |
| 00840682144247 | S8 R4 OLED |
| 00840682143998 | P9 R2.5 to R3 UPG |
| 00840682143967 | P7 R2.5 to R3 UPG |
| 00840682142793 | S8 R4 LCD |
| 00840682141314 | P7 R3 |
| 00840682141260 | P9 R2_2.5 to R3 UPG |
| 00840682141253 | P7 R2_2.5 to R3 UPG |
| 00840682141246 | P9 R3 |
| 00840682122979 | S8 R4 |
| 00840682122962 | S8 R3 to R4 UPG |
| 00840682122887 | P9 R2 to R2.5 UPG |
| 00840682122634 | P7 R2.5 |
| 00840682122627 | P9 R2.5 |
| 00840682118408 | P9 R1 to R2 UPG |
| 00840682117821 | S8 R1 to R2 UPG |
| 00840682117791 | S8 R1R2 to R3 UPG |
| 00840682117753 | S8 |
| 00840682117623 | S7 R2 to R3 UPG |
| 00840682117432 | S7 R1 to R2 UPG |
| 00840682117005 | P9 R1 to R2 UPG |
| 00840682115988 | P9 R2 |
| 00840682115933 | P7 R2 |
| 00840682110938 | P9 |
| 00840682106511 | S7 R3 |
| 00840682146531 | E10s |
| 00195278029010 | S8 R3 OLED |
| 00195278236005 | LOGIQ P10 R4 HD |
| 00195278111272 | LP9 R3 to R4 SW Conversion |
| 00195278111265 | LOGIQ P10 R4 |
| 00195278111258 | LOGIQ P9 R4 |
| 00195278111241 | LOGIQ P8 R4 |
| 00195278410245 | LOGIQ E10s R3 OLED |
| 00195278410221 | LOGIQ E10s R3 |
| 00195278405333 | LOGIQ Fortis LCD Console |
| 00195278405326 | LOGIQ Fortis HDU Console |
| 00195278487414 | LOGIQ E10s R2 to R3 UPG |
| 00195278464675 | LP9 R4 to R4.5 SW Conversion |
| 00195278464668 | LOGIQ P10 R4.5 HD |
| 00195278464651 | LP8 R4 to R4.5 SW Conversion |
| 00195278464644 | LOGIQ P10 R4.5 |
| 00195278464637 | LOGIQ P9 R4.5 |
| 00195278464620 | LP10 R4 to R4.5 SW Conversion |
| 00195278464613 | LOGIQ P8 R4.5 |
| 00195278722966 | LOGIQ E10s R4 |
| 00195278722959 | LOGIQ Fortis R4 HDU CONSOLE |
| 00195278722942 | LOGIQ Fortis R4 LCD CONSOLE |
| 00195278724342 | LOGIQ Totus HDU |
| 00195278664600 | LOGIQ Totus |
| 00195278835802 | LOGIQ Fortis R3 to R4 Upgrade with Hardware |
Trademark Results [LOGIQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOGIQ 97052151 not registered Live/Pending |
Logiq, Inc. 2021-09-29 |
 LOGIQ 97052135 not registered Live/Pending |
Logiq, Inc. 2021-09-29 |
 LOGIQ 97052101 not registered Live/Pending |
Logiq, Inc. 2021-09-29 |
 LOGIQ 90658332 not registered Live/Pending |
Wheel Pros, LLC 2021-04-20 |
 LOGIQ 90568663 not registered Live/Pending |
Wheel Pros, LLC 2021-03-09 |
 LOGIQ 88212476 not registered Live/Pending |
Maple Mountain Group, Inc. 2018-11-30 |
 LOGIQ 87676367 5740753 Live/Registered |
Iscar Ltd. 2017-11-08 |
 LOGIQ 87676316 5740752 Live/Registered |
Iscar Ltd. 2017-11-08 |
 LOGIQ 86389657 4911950 Live/Registered |
logiq LLC 2014-09-09 |
 LOGIQ 78265775 3280386 Live/Registered |
Halliburton Energy Services, Inc. 2003-06-23 |
 LOGIQ 78166131 not registered Dead/Abandoned |
MERRELL PHARMACEUTICALS INC. 2002-09-20 |
 LOGIQ 77103527 3468732 Live/Registered |
Halliburton Energy Services, Inc. 2007-02-09 |
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