DEVICE: Hitachi (04562122958868)
Device Identifier (DI) Information
Hitachi
ALOKA LISENDO 880
Not in Commercial Distribution
HITACHI, LTD.
ALOKA LISENDO 880
Not in Commercial Distribution
HITACHI, LTD.
Diagnostic Ultrasound System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
No | |
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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? |
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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 |
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ITX | Transducer, Ultrasonic, Diagnostic |
IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
98a1253a-6fc2-4847-8663-18637df590fa
July 05, 2021
5
December 22, 2016
July 05, 2021
5
December 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined