DEVICE: SonoBook Series Diagnostic Ultrasound Systems (06945121411172)
Device Identifier (DI) Information
SonoBook Series Diagnostic Ultrasound Systems
SonoBook 9
In Commercial Distribution
CHISON Medical Technologies Co., Ltd.
SonoBook 9
In Commercial Distribution
CHISON Medical Technologies Co., Ltd.
No description.
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? |
|---|---|---|---|---|
| 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 |
|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K170374 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
fcaa5706-41db-49e6-8b66-7dc02a1b43fa
September 05, 2022
5
February 02, 2018
September 05, 2022
5
February 02, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 06945121411981 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411974 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411967 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411837 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411820 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411813 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411806 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411790 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411783 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411776 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411769 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411752 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411745 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411738 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411721 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411844 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411851 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411868 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411875 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411882 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411899 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411905 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411912 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411929 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411936 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411943 | 1 | 06945121411172 | In Commercial Distribution | ||
| 06945121411950 | 1 | 06945121411172 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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