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MiniCATIQ

FDA UDI

Class II (US FDA UDI)

by Xoran Technologies, LLC

Identity

Trade Name
MiniCATIQ FDA UDI
Generic Name
Cone beam computed tomography system, head/neck FDA UDI
Device Name
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. FDA UDI
Model / Reference
10009 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860290000315 FDA UDI
510(k) Number
K113421 FDA UDI
FDA Product Code
JAK FDA UDI
GMDN Term
Cone beam computed tomography system, head/neck FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cone beam computed tomography system, head/neck

MiniCATIQ by Xoran Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cone beam computed tomography system, head/neck.

Cleared under the same submission

K113421 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xoran Technologies, LLC

Sources (1)

  • FDA UDI a736e101-0e82-4267-85a8-022e7eedae73 34 fields · synced Jun 1, 2026