DEVICE: Q Series Diagnostic Ultrasound System (06945121400060)

Device Identifier (DI) Information

Q Series Diagnostic Ultrasound System
Q9
In Commercial Distribution

CHISON Medical Technologies Co., Ltd.
06945121400060
GS1

1
544914187 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
IYN System, Imaging, Pulsed Doppler, Ultrasonic
IYO System, Imaging, Pulsed Echo, Ultrasonic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153085 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c64d5cc9-60ab-4e14-8d8e-0135bf776612
July 06, 2018
4
September 24, 2016
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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
06945121402330 1 06945121400060 In Commercial Distribution
06945121402323 1 06945121400060 In Commercial Distribution
06945121402316 1 06945121400060 In Commercial Distribution
06945121402309 1 06945121400060 In Commercial Distribution
06945121402170 1 06945121400060 In Commercial Distribution
06945121402163 1 06945121400060 In Commercial Distribution
06945121402156 1 06945121400060 In Commercial Distribution
06945121402149 1 06945121400060 In Commercial Distribution
06945121402132 1 06945121400060 In Commercial Distribution
06945121402125 1 06945121400060 In Commercial Distribution
06945121402118 1 06945121400060 In Commercial Distribution
06945121402101 1 06945121400060 In Commercial Distribution
06945121402095 1 06945121400060 In Commercial Distribution
06945121402088 1 06945121400060 In Commercial Distribution
06945121402071 1 06945121400060 In Commercial Distribution
06945121402064 1 06945121400060 In Commercial Distribution
06945121402187 1 06945121400060 In Commercial Distribution
06945121402194 1 06945121400060 In Commercial Distribution
06945121402200 1 06945121400060 In Commercial Distribution
06945121402217 1 06945121400060 In Commercial Distribution
06945121402224 1 06945121400060 In Commercial Distribution
06945121402231 1 06945121400060 In Commercial Distribution
06945121402248 1 06945121400060 In Commercial Distribution
06945121402255 1 06945121400060 In Commercial Distribution
06945121402262 1 06945121400060 In Commercial Distribution
06945121402279 1 06945121400060 In Commercial Distribution
06945121402286 1 06945121400060 In Commercial Distribution
06945121402293 1 06945121400060 In Commercial Distribution
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Secondary DI

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

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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

[?]
No Customer Contact currently defined
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