Micro C Medical Imaging System M01
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203658 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Micro C Medical Imaging System M01 is a mobile X-ray system designed for portable radiographic imaging. It is classified as a Class II device and functions as a handheld, general-purpose X-ray system capable of producing static and serial radiographic exposures. This system is intended for use in radiology settings to capture high-quality images of extremities in both adult and pediatric patients.
The device is supplied as a reusable medical imaging system and is intended for use by qualified clinicians. It is not specified as MRI-safe or sterile, and its regulatory status includes FDA 510(k) clearance under the classification IZL. The system operates within the regulatory framework of 21 CFR 892.1720 and is intended for diagnostic imaging purposes in clinical environments. Storage and handling instructions are not detailed in the provided data.
Frequently asked questions
What is the Micro C Medical Imaging System M01 used for?
The Micro C Medical Imaging System M01 is a portable radiographic imaging device designed specifically for capturing high-quality static and serial X-ray images of extremities. It is intended for use in radiology settings to assist clinicians in diagnosing conditions affecting adult and pediatric patients’ limbs, such as fractures, dislocations, or bone abnormalities.
Is the Micro C M01 system reusable or single-use?
The Micro C M01 is supplied as a reusable medical imaging system. Unlike single-use devices, it is built for repeated use in clinical environments, provided it is properly maintained and cleaned according to manufacturer guidelines. Reusability helps reduce waste and costs while ensuring consistent performance.
Does the Micro C M01 come pre-sterilized or require sterilization?
The provided data does not specify whether the Micro C M01 is pre-sterilized or requires sterilization before use. Since it is a reusable device, it is likely intended to be cleaned and sterilized between uses in accordance with standard medical device reprocessing protocols. Clinicians should follow the manufacturer’s instructions for cleaning and sterilization to ensure safety and functionality.
What regulatory approval does the Micro C M01 hold?
The Micro C Medical Imaging System M01 holds FDA 510(k) clearance under the classification IZL, which falls under the regulatory framework of 21 CFR 892.1720. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting the FDA’s requirements for safety and effectiveness in its intended use.
Are there different models or sizes available for the Micro C M01?
The provided data does not specify multiple models or sizes for the Micro C M01 system. However, the system is described as a general-purpose handheld X-ray device, which may imply flexibility in use across different patient sizes (adults and pediatric). For precise sizing or model variations, clinicians should refer to the manufacturer’s documentation or contact Oxos Medical, Inc. directly.
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: Introducing Micro C - OXOS Medical Imaging, About OXOS Medical | Redefining Portable X-ray, Portable X-ray Solutions from OXOS, Micro C Medical Imaging System, M01 (K212654) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203658 | Class II | Active |
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Manufacturer
- Manufacturer
- OXOS Medical, Inc.
Sources (1)
- FDA 510(k) K203658 24 fields · synced Oct 1, 2026