DEVICE: Imagio® (00864802000442)

Device Identifier (DI) Information

Imagio®
8100
In Commercial Distribution
8100-181-00
Seno Medical Instruments, Inc.
00864802000442
GS1

1
615062499 *Terms of Use
Transducer (OA/US Probe) Model 8100
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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.
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QNK Optoacoustic Imaging System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P200003 001
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d3453b97-2a52-4834-b4cb-a8ad1642324a
July 17, 2023
1
July 07, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
888-978-8835
service@senomedical.com
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