DEVICE: Invenia (00840682100038)
Device Identifier (DI) Information
Invenia
ABUS Workstation
In Commercial Distribution
H5014WS
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Workstation
In Commercial Distribution
H5014WS
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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40764 | Breast ultrasound imaging system |
An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PAA | Automated Breast Ultrasound |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P110006 | 001 |
P110006 | 002 |
P110006 | 003 |
P110006 | 004 |
P110006 | 005 |
P110006 | 006 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Storage Altitude: 0 to 5,000m |
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 14 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6347751d-3e6f-4b2b-9feb-e1ae3fbca5ef
May 10, 2021
5
September 24, 2014
May 10, 2021
5
September 24, 2014
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