DEVICE: LOGIQ (00195278835796)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
LOGIQ
E10s R2R3 to R4 SW Upgade
In Commercial Distribution
5946721
GE Ultrasound Korea Ltd.
00195278835796
GS1

1
690168810 *Terms of Use
LOGIQ E10s R2/R3 to R4 SW Upgrade
CLOSE

Device Characteristics
MR Unsafe
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, ultrasonic, diagnostic
IYN System, imaging, pulsed doppler, ultrasonic
IYO System, imaging, pulsed echo, ultrasonic
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K231989 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
5fc7e1d2-93aa-454d-8abc-cfa74aeaded8
March 12, 2024
1
March 04, 2024
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE