AccessGUDID - DEVICE: X-MIND trium (D804W09000040)

GUDID

Device Identifier (DI) Information

Brand Name: X-MIND trium
Version or Model: XMT PAN 3D R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: W0900004
Company Name: DE GÖTZEN SRL

Primary DI Number: D804W09000040
Issuing Agency: HIBCC
Commercial Distribution End Date: December 15, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 433051802 *Terms of Use

Device Description: X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the right

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61019	Cone beam computed tomography system, head/neck	A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.	Active	false
44245	Stationary panoramic/tomographic dental x-ray system, digital	A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUH	System,X-Ray,Extraoral Source,Digital
OAS	X-Ray, Tomography, Computed, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160166	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 85 and 106 KiloPascal
Handling Environment Humidity: between 25 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 25 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e04d79a6-c305-43a1-a367-76c13cbbb960
Public Version Date: April 25, 2023
Public Version Number: 4
DI Record Publish Date: December 15, 2016