DEVICE: MiniX-S (08800021800021)

Device Identifier (DI) Information

MiniX-S
1
In Commercial Distribution
1
DigiMed Co., Ltd.
08800021800021
GS1

1
688265810 *Terms of Use
The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The device is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both.
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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?
44606 Hand-held intraoral dental x-ray system, digital
A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EHD Unit, X-Ray, Extraoral With Timer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

dba0ff16-f300-4520-a67a-ff2e050b8e0b
April 01, 2019
4
January 19, 2018
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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
88800021800027 8 08800021800021 In Commercial Distribution Carton Package
78800021800020 7 08800021800021 In Commercial Distribution Carton Package
68800021800023 6 08800021800021 In Commercial Distribution Carton Package
58800021800026 5 08800021800021 In Commercial Distribution Carton Package
48800021800029 4 08800021800021 In Commercial Distribution Carton Package
38800021800022 3 08800021800021 In Commercial Distribution Carton Package
28800021800025 2 08800021800021 In Commercial Distribution Carton Package
18800021800028 1 08800021800021 In Commercial Distribution Carton Package
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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

[?]
+82226241552
fredchoi@digimed.co.kr
+82226241551
digimed@digimed.co.kr
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