DEVICE: LOGIQ (00840682145640)
Device Identifier (DI) Information
LOGIQ
E10 R2
In Commercial Distribution
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
E10 R2
In Commercial Distribution
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
LOGIQ E10 R2 Console
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system |
A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IYN | System, imaging, pulsed doppler, ultrasonic |
| ITX | Transducer, ultrasonic, diagnostic |
| IYO | System, imaging, pulsed echo, ultrasonic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Handling Environment Temperature: between -20 and 60 Degrees Celsius |
| Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Height: 1300 Millimeter |
| Length: 901 Millimeter |
| Width: 585 Millimeter |
Device Record Status
bb2681ca-abbc-4c92-91a0-2eca269c86e3
September 23, 2024
2
May 04, 2020
September 23, 2024
2
May 04, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)437-1171
xx@xx.xx
xx@xx.xx