# K162011: MedDream

- Pathway: 510(k) (Traditional)
- Applicant: Softneta Uab
- Decided: Oct 14, 2016 after 85 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200546: ZeeroMED View (2020), 6 descendants of its own
- K233226: FlexView Diagnostic (v1.1.20) (2024), 2 descendants of its own
- K221065: MediLab (2022), 1 descendant of its own
- K262449: AdvaView (2026), 0 descendants of its own
- K253784: 3DICOM MD Cloud (2026), 0 descendants of its own

## Indications for use
MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians. Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data.

Source page: https://510kreport.com/device/K162011
Methodology: https://510kreport.com/methodology