MedDream
by Softneta Uab Lithuania EUDAMED510(k)
510(k) K162011
Product code LLZ
Overview
MedDream is a medical imaging device classified under product code LLZ, intended for diagnostic radiology applications. It functions as a digital imaging system designed to capture and process radiographic images for clinical evaluation, supporting radiologic assessments in healthcare settings.
The device is supplied by Softneta UAB, based in Kaunas, Lithuania, and is authorized under FDA 510K clearance (K162011) and MDR compliance. It is intended for single-use or reusable configurations as specified in its design, with no explicit MRI safety classification noted in the data. Storage and handling instructions are not provided in the specifications, but regulatory filings confirm its substantial equivalence to existing radiology devices under the Traditional 510(k) pathway.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK162011 | Date14 Oct 2016 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Softneta Uab
Questions
What types of medical imaging assessments is the MedDream device designed to support in clinical settings?
The MedDream is a digital imaging system classified under product code LLZ, intended specifically for diagnostic radiology applications. This means it is designed to capture and process radiographic images for clinical evaluation, aiding radiologic assessments such as X-rays, which are commonly used to diagnose fractures, infections, or other internal conditions.
Is the MedDream device intended for single-use or reusable configurations, and how should it be handled?
The MedDream device can be configured for either single-use or reusable applications, depending on its specific design. While the regulatory filings confirm its substantial equivalence to existing radiology devices, they do not provide explicit storage or handling instructions. Clinicians should refer to the manufacturer’s provided guidelines for proper use, maintenance, and disposal to ensure compliance and safety.
What regulatory pathways does the MedDream device follow, and how does this affect its use in healthcare settings?
The MedDream device is authorized under both FDA 510(k) clearance (K162011) and MDR compliance, indicating it has undergone regulatory review to demonstrate substantial equivalence to existing radiology devices. This clearance confirms its safety and effectiveness for diagnostic radiology applications, allowing healthcare providers to rely on it for clinical imaging purposes as intended.
Does the MedDream device have any specific safety considerations related to MRI environments?
The provided data does not mention any explicit MRI safety classification for the MedDream device. If MRI compatibility is a concern, clinicians should verify with the manufacturer or consult the device’s technical documentation to ensure safe use in environments where MRI equipment is present.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K162011
- EUDAMED