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MiniCATIQ

XORAN TECHNOLOGIES LLC · Model 10009 · UDI-DI 00860290000315

JAK

510(k) clearances

5,267

Adverse events (219 deaths)

865

Recalls

163

Facilities

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.

Recalls

Date	Firm	Reason
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-08-07	Philips North America Llc	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
2026-06-26	Philips Healthcare (Suzhou) Co., Ltd.	Potential of failing to trigger clinical scan during Bolus Tracking.
2026-06-11	PHILIPS MEDICAL SYSTEMS	The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i
2026-06-11	PHILIPS MEDICAL SYSTEMS	The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i
2026-06-11	PHILIPS MEDICAL SYSTEMS	The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i
2026-03-26	GE Medical Systems, LLC	GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with
2026-03-26	GE Medical Systems, LLC	GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.