AccessGUDID - DEVICE: MiniCATIQ (00860290000315)

GUDID

Device Identifier (DI) Information

Brand Name: MiniCATIQ
Version or Model: 10009
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XORAN TECHNOLOGIES LLC

Primary DI Number: 00860290000315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079255809 *Terms of Use

Device Description: MiniCATIQ is a compact, upright volume computed tomography system designed for highresolution, bone window imaging of the sinuses, temporal bones, and skull base. MiniCATIQ provides immediate access to images at the patient’s point-of-care resulting in a faster diagnosis and treatment. The MiniCATIQ is an X-ray imaging device that constructs a three-dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCATIQ is optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses.

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):	No
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

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113421	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a736e101-0e82-4267-85a8-022e7eedae73
Public Version Date: October 03, 2024
Public Version Number: 4
DI Record Publish Date: September 20, 2016