FDA.reportPublic FDA data

MiniCATIQ

Primary DI
00860290000315
Brand
MiniCATIQ
Company
XORAN TECHNOLOGIES LLC
Model
10009
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 ina faster diagnosis and treatment.The MiniCATIQ is an X-ray imaging device that constructs a three-dimensional model ofthe head and neck from images taken during a rotational X-ray sequence. The MiniCATIQis optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113421000MINICATXoran Technologies, Inc.2012-07-11JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860290000315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860290000315008602900003158602900003150860290000315

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, head/neckA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079255809
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008443755MiniCATIQ+100402024-10-02
00860008443731MiniCATIQ100152024-01-29
00860008443748MiniCAT 2D100312024-01-29
00860008443717Xoran Workstationv.52024-01-18
00860008443724MiniCAT 2D100352023-07-26
00860008443700TRON110502023-01-12
00860290000384XoranConnectv.62022-08-15
00860290000391Xoran Workstationv5.15.52021-06-16
00860290000377MiniCAT 2D100302020-12-14
00860290000360xCAT IQ110202019-06-17
00860290000353MiniCAT2020100202018-07-16
00860290000308MiniCAT100042016-09-20
00860290000322XoranConnect5.22016-09-22
00860290000339xCAT110002017-06-28
00860290000346xCAT XL110102018-04-10

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Primary DI, Brand, Company table
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M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
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M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
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