LOGIQ

GUDID 00195278410221

LOGIQ E10s R3

GE Ultrasound Korea Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 00195278410221
• NIH Device Record Key: 0a94be8a-4afd-4e37-8ac5-870a96f85eb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOGIQ
• Version Model Number: E10s R3
• 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: false
• 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
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx
• Phone: +1(800)437-1171
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278410221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211524

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2021-11-22
• Device Publish Date: 2021-11-12

On-Brand Devices [LOGIQ]

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• 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