MedDream
by Softneta Uab Lithuania EUDAMED510(k)
510(k) K222320
Product code LLZ
Overview
MedDream is a Diagnostic Imaging Device designed for use in radiology procedures. It functions as a digital imaging system, likely intended for capturing and processing radiographic images, though its exact clinical application is not specified in the data.
The device is supplied by Softneta UAB and is classified under the product code LLZ in the FDA’s regulatory framework. It is substantially equivalent to a predicate device, as determined by the Radiology (RA) Advisory Committee, and has received FDA 510K clearance and MDR authorization. No details on sterility, single-use, or MRI safety are provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222320 | Date6 Dec 2022 | 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 is the primary purpose of the MedDream device in a clinical setting?
The MedDream is a digital imaging system designed for use in radiology procedures, specifically for capturing and processing radiographic images. While the exact clinical applications aren’t detailed, its classification under FDA product code LLZ (Radiology) and its review by the Radiology (RA) Advisory Committee confirm its role in diagnostic imaging workflows, such as X-ray or similar modalities.
How is the MedDream device supplied, and what should buyers expect in terms of packaging?
The provided data does not specify details about the packaging, sterility, or single-use/reuse status of the MedDream device. Since it is a diagnostic imaging system (not a consumable or disposable), it is likely supplied as a complete unit rather than pre-packaged components. Buyers should confirm these logistics directly with Softneta UAB, as the device’s physical form and handling requirements aren’t outlined in the regulatory submission.
Is the MedDream device intended for single-use or repeated use in a clinical environment?
The data does not mention whether the MedDream is single-use or reusable. As a digital imaging system, it is more likely designed for repeated use in radiology departments, but this would depend on its mechanical and software components. Buyers should verify maintenance requirements, cleaning protocols, and manufacturer guidelines with Softneta UAB, as these details are critical for operational planning.
What regulatory pathways has the MedDream device undergone, and how does this affect its market availability?
The MedDream has received FDA 510K clearance (via a Traditional review by the Radiology Advisory Committee) and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. Its classification as substantially equivalent (SESE) to a predicate device under product code LLZ ensures it meets established safety and performance benchmarks for radiology imaging systems. Availability depends on these clearances, but buyers should confirm regional compliance (e.g., FDA vs. CE marking) with Softneta UAB.
What contact information should a buyer use to inquire about technical specifications or ordering details?
For inquiries about the MedDream’s technical specifications, ordering, or operational details, buyers can reach Softneta UAB at the provided address: K.Barsausko St. 59, Kaunas, LT-51423. The contact person listed is Laura Baroniene, though her direct email or phone number isn’t specified in the data. Buyers should also verify if additional regional distributors or support teams are available for their location.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K222320
- EUDAMED