DEVICE: MiniX-S (08800021800021)
Device Identifier (DI) Information
MiniX-S
1
In Commercial Distribution
1
DigiMed Co., Ltd.
1
In Commercial Distribution
1
DigiMed Co., Ltd.
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.
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EHD | Unit, X-Ray, Extraoral With Timer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
dba0ff16-f300-4520-a67a-ff2e050b8e0b
April 01, 2019
4
January 19, 2018
April 01, 2019
4
January 19, 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 |
---|---|---|---|---|---|
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 |
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
[?]
+82226241552
fredchoi@digimed.co.kr +82226241551
digimed@digimed.co.kr
fredchoi@digimed.co.kr +82226241551
digimed@digimed.co.kr