DEVICE: EchoSure (B53670000)
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Device Identifier (DI) Information
EchoSure
7000
In Commercial Distribution
SONAVEX, INC.
7000
In Commercial Distribution
SONAVEX, INC.
The EchoSure diagnostic ultrasound system and its transducer are intended for use in clinical examinations of blood vessels that are marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 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 |
|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| ITX | Transducer, Ultrasonic, Diagnostic |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K190039 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
cacdf335-c564-4fa4-b36c-3ca011cde3a9
April 22, 2026
1
April 14, 2026
April 22, 2026
1
April 14, 2026
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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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