Identifiers
- 510(k) Number
- K080890 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SmartSPOT PrimaX RF is a radiography imaging system designed for high-resolution digital X-ray capture. Classified under product code LLZ, it is intended for use in diagnostic radiology procedures to produce detailed images of internal body structures for medical evaluation.
This device is supplied as a reusable medical imaging system, intended for use in radiology departments within healthcare facilities. It is regulated under 21 CFR 892.2050 and holds FDA 510(k) clearance (K080890) as substantially equivalent to a predicate device, with no third-party review. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What types of medical evaluations is the SmartSPOT PrimaX RF designed to assist with through its high-resolution imaging capabilities?
The SmartSPOT PrimaX RF is specifically designed for diagnostic radiology procedures, enabling detailed imaging of internal body structures. This makes it suitable for evaluating bones, organs, and other anatomical features where precise visualization is critical, such as fractures, joint conditions, or internal abnormalities.
Is the SmartSPOT PrimaX RF intended for single-use or can it be reused in a clinical setting?
The SmartSPOT PrimaX RF is supplied as a reusable medical imaging system, meaning it is engineered for repeated use within radiology departments. This design allows healthcare facilities to maintain consistent imaging quality over time without the need for disposable components.
How is the SmartSPOT PrimaX RF regulated, and what does its FDA clearance status indicate?
The SmartSPOT PrimaX RF holds FDA 510(k) clearance (K080890) under product code LLZ, classified under radiology. The clearance indicates it is deemed *substantially equivalent* to a predicate device, meaning it meets the same performance standards and safety requirements as an existing approved device. The classification under 21 CFR 892.2050 further confirms its regulatory pathway for diagnostic X-ray systems.
Does the SmartSPOT PrimaX RF require any special handling or storage conditions to maintain its performance?
The available data does not specify special storage conditions for the SmartSPOT PrimaX RF, but as a reusable medical imaging system, it should be stored in a clean, dry environment to prevent damage or contamination. Proper maintenance and calibration per manufacturer guidelines will ensure optimal imaging quality and longevity.
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. Sources consulted: CMT SmartSPOT PrimaX RF Overview | PDF | Medical Imaging - Scribd, Cmt Smartspot Primax - allmed.wiki, SMARTSPOT PRIMAX (K080890) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080890 | Class II | Active |
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Manufacturer
- Manufacturer
- CMT Medical Technologies, Ltd.
Sources (1)
- FDA 510(k) K080890 24 fields · synced Sep 19, 2026