DEVICE: Imagio® (00864802000442)
Device Identifier (DI) Information
Imagio®
8100
In Commercial Distribution
8100-181-00
Seno Medical Instruments, Inc.
8100
In Commercial Distribution
8100-181-00
Seno Medical Instruments, Inc.
Transducer (OA/US Probe) Model 8100
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? |
---|---|---|---|---|
61018 | Optoacoustic/ultrasound imaging system |
A mobile assembly of electrically-powered devices intended for imaging and analysis of soft-tissue and soft-tissue vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging. It includes a processing unit with a monitor, controls, and integrated software, and a dedicated laser-emitting extracorporeal ultrasound transducer. Pulsed near-infrared laser light of various wavelengths is emitted and the associated acoustic feedback (photoacoustic effect) provides complementary information regarding tissue composition/functionality based on the presence of endogenous chromophores, such as haemoglobin; this photoacoustic data can be overlaid on the associated US image.
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Active | false |
40768 | Extracorporeal ultrasound imaging transducer, hand-held |
A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QNK | Optoacoustic Imaging System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P200003 | 001 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d3453b97-2a52-4834-b4cb-a8ad1642324a
July 17, 2023
1
July 07, 2023
July 17, 2023
1
July 07, 2023
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
[?]
888-978-8835
service@senomedical.com
service@senomedical.com