Digital Radiography System (ManntiX B, ManntiX K)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240841 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 Digital Radiography System (ManntiX B, ManntiX K) is a mobile, portable digital X-ray imaging device designed for capturing high-resolution radiographic images. It operates as a System, X-Ray, Mobile (per FDA classification) and is intended for radiologic examinations of anatomical regions including the head, spine, chest, abdomen, pelvis, and extremities.
This system comprises key components such as a portable X-ray assembly, X-ray protective device, mobile stand, digital detector, and image processing system. Supplied as a reusable medical device, it requires compliance with FDA 510(k) clearance (K240841) and MDR authorization, with regulatory classification under device class 2 and regulation number 892.1720. The system is intended for use in radiology settings and may include multiple FEI numbers (e.g., 3015223550, 3003775006) for regulatory tracking.
Frequently asked questions
What anatomical regions can the ManntiX B and ManntiX K systems capture radiographic images of?
The Digital Radiography System (ManntiX B, ManntiX K) is designed for capturing high-resolution radiographic images of multiple anatomical regions, including the head, spine, chest, abdomen, pelvis, and extremities. This versatility makes it suitable for a wide range of radiologic examinations in clinical settings.
Is the ManntiX system portable, and how does this affect its use in clinical settings?
Yes, the ManntiX system is explicitly described as a mobile, portable digital X-ray imaging device. This portability allows for flexible use in various clinical environments, such as emergency rooms, operating rooms, or patient wards, where mobility is advantageous for capturing images without relocating the patient.
How is the ManntiX system supplied, and is it intended for single-use or reuse?
The system is supplied as a reusable medical device, meaning it is designed for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. This aligns with its classification as a System, X-Ray, Mobile under FDA guidelines, where durability and reusability are standard for such equipment.
What regulatory pathways has the manufacturer followed for the ManntiX system, and what does this imply for its use?
The manufacturer, Shenzhen Browiner Tech Co., Ltd., has obtained FDA 510(k) clearance (K240841) and MDR authorization, with the system classified under device class 2 and regulation number 892.1720. This implies the device has undergone rigorous evaluation for safety and performance, ensuring compliance with both U.S. and EU regulatory standards before clinical use.
Does the system include any specific components that may require special handling or maintenance?
Yes, the system comprises several key components, including a portable X-ray assembly, X-ray protective device, mobile stand, digital detector, and image processing system. While the system is reusable, proper handling of the X-ray assembly and protective components is critical to ensure radiation safety and maintain image quality. Regular maintenance of the digital detector and image processing system is also recommended to sustain performance.
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 (ManntiX B, ManntiX K) by Shenzhen Browiner ..., Digital Radiography System (ManntiX B, ManntiX K), K240841 - Digital Radiography System (ManntiX B | FDA 510(k)
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 | K240841 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Browiner Tech Co., Ltd.
Sources (2)
- FDA 510(k) K240841 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026