Hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by CEFLA s.c.
Identifiers
- 510(k) Number
- K190496 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hyperion X9 Pro, NewTom GiANO HR, and X-RADiUS TRiO PLUS are computed dental tomography systems designed for high-resolution imaging of dental and maxillofacial structures. These devices provide three-dimensional volumetric imaging, enabling detailed visualization of teeth, bone, and surrounding anatomy for diagnostic and treatment planning purposes in radiology.
These systems are intended for use in clinical settings, supplied as reusable medical devices, and comply with FDA 510(k) and MDR regulations. They are classified as Class II devices and feature multiple configurations for varying patient sizes and imaging requirements. Storage and handling follow standard medical device protocols to ensure operational integrity and patient safety.
Frequently asked questions
Are these computed dental tomography systems reusable or single-use, and what does that mean for maintenance and cleaning protocols?
The Hyperion X9 Pro, NewTom GiANO HR, and X-RADiUS TRiO PLUS are reusable medical devices, meaning they are designed for repeated use in clinical settings. Since they are not single-use, they require adherence to standard medical device maintenance and cleaning protocols to ensure operational integrity, patient safety, and compliance with regulatory standards. Proper sterilization and upkeep are essential to prevent contamination and maintain imaging accuracy over time.
What types of patient sizes or configurations are available for these computed dental tomography systems?
These systems—Hyperion X9 Pro, NewTom GiANO HR, and X-RADiUS TRiO PLUS—feature multiple configurations tailored to accommodate varying patient sizes and imaging requirements. While the exact configurations aren’t detailed here, their design emphasizes versatility for dental and maxillofacial imaging, ensuring adaptability for different clinical scenarios, including pediatric and adult patients.
How are these devices regulated, and what does that mean for purchasing or using them in a clinical setting?
These devices are regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), classifying them as Class II devices. The FDA’s clearance (via a traditional 510(k) pathway) and MDR compliance ensure they meet stringent safety and performance standards. For purchasing or use, this means they must be procured through authorized distributors, installed by trained personnel, and maintained according to regulatory guidelines to ensure proper functionality and patient safety.
What storage and handling requirements should be followed to maintain the operational integrity of these computed tomography systems?
Like all reusable medical devices, these systems require adherence to standard medical device storage and handling protocols to preserve their operational integrity. This includes protecting them from physical damage, environmental contaminants, and improper exposure to moisture or extreme temperatures. Manufacturers typically provide specific guidelines, but general best practices involve keeping them in a clean, controlled environment and following maintenance schedules to ensure longevity and reliability.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190496 | Class II | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
Sources (2)
- FDA 510(k) K190496 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026