Digital Radiography System - MobileApex 60E
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240284 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
- Models / Variants
- MobileApex 60E FDA 510(k)EUDAMED
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 MobileApex 60E, 60F, 60G, and 60H are mobile digital X-ray systems designed for portable radiography. These devices generate real-time radiographic images using digital detectors, enabling high-resolution imaging at the patient’s bedside or in non-traditional imaging environments. They are classified as mobile X-ray systems under the nomenclature authority’s definition, facilitating flexible diagnostic imaging without requiring patients to be moved to a fixed radiology suite.
These systems are intended for use in clinical radiology settings, providing single-use or reusable components as specified by the manufacturer. They are regulated under FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, with each model variant (60E, 60F, 60G, 60H) assigned distinct registration numbers. The devices are not MRI-compatible and require proper storage in a controlled environment to maintain performance and sterility. No additional regulatory status beyond the stated authorizations is implied.
Frequently asked questions
Are the MobileApex 60E, 60F, 60G, and 60H systems designed for use in MRI environments, or do they require special precautions when used near MRI equipment?
The MobileApex 60E, 60F, 60G, and 60H systems are explicitly not MRI-compatible. Since they are mobile digital X-ray systems, they contain metallic and electronic components that could pose risks in an MRI environment, such as interference or potential injury from magnetic fields. Always follow strict protocols for non-MRI-compatible devices when operating near MRI equipment, including proper shielding and patient safety measures.
How are the MobileApex 60 series systems regulated, and what does the FDA 510(k) clearance and MDR compliance mean for purchasing or using these devices?
The MobileApex 60E, 60F, 60G, and 60H systems are regulated under FDA 510(k) clearance (traditional pathway, substantially equivalent to a predicate device) and MDR (Medical Device Regulation) compliance. This means they have undergone regulatory review to confirm safety and performance standards in the U.S. and EU markets, respectively. Purchasers should verify that the device’s registration numbers (listed in the specifications) match their intended use and that local regulations are followed for installation, maintenance, and operation.
Can the MobileApex 60 series systems be used with reusable components, or are they designed for single-use only?
The MobileApex 60 series systems are designed for use with both single-use and reusable components, depending on the specific part or accessory. The manufacturer specifies whether individual components (e.g., detectors, cassettes, or accessories) are intended for single-use or can be reused after proper cleaning and sterilization. Always refer to the manufacturer’s instructions for each component to ensure compliance with infection control and maintenance protocols.
What storage conditions are required to maintain the performance and sterility of the MobileApex 60 series systems?
The MobileApex 60 series systems require controlled storage environments to preserve performance and sterility. While the exact specifications aren’t detailed here, mobile X-ray systems typically need protection from extreme temperatures, humidity, dust, and physical damage. Single-use components should be stored according to their expiration dates, and reusable parts must undergo proper cleaning and sterilization before reuse. Always follow the manufacturer’s guidelines for storage and handling.
How do I determine which MobileApex 60 model (E, F, G, or H) is best suited for my clinical setting?
The MobileApex 60E, 60F, 60G, and 60H models are distinct variants with unique registration numbers, but the manufacturer does not specify clinical differences between them in the provided data. To determine the best fit, consider factors like image resolution requirements, portability needs, power source compatibility, or specific clinical workflows (e.g., pediatric vs. adult imaging). Contact Shenzhen Browiner Tech Co., Ltd. for detailed technical specifications or consult your radiology team to align the system with your facility’s diagnostic needs.
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: Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex ..., PDF K240284 - Digital Radiography System (MobileApex 60E, MobileApex 60F ..., K240284 - Digital Radiography System (MobileApex 60E, Browiner: Medical X-ray solution Manufacturer & Supplier, Shenzhen Browiner Tech Digital Radiography (MobileApex 60E…
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 | K240284 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Browiner Tech Co., Ltd.
Sources (2)
- FDA 510(k) K240284 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026