AccessGUDID - DEVICE: myray (08033837931454)

GUDID

Device Identifier (DI) Information

Brand Name: myray
Version or Model: hyperion X5 (3D)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X53D016
Company Name: CEFLA SOCIETA' COOPERATIVA

Primary DI Number: 08033837931454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429341410 *Terms of Use

Device Description: Extraoral Xray system for digital Xrays imaging suitable for: - production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity - produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, stmctures of the oral cavity and some cranial bones

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?
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 [?]
K161900	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
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 71 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f63b831-e123-4719-afb8-e544385e2797
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 24, 2017