# K200546: ZeeroMED View

- Pathway: 510(k) (Traditional)
- Applicant: O3 Enterprise Srl
- Decided: May 5, 2020 after 63 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
Longest line of descent: 1 generation back to K162011 (2016). 1 ancestor in all.
6 later devices descend from it; 3 cite 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)
- K162011: MedDream, Softneta Uab (2016) Summary page 6.

## Most influential descendants
- 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
- K223048: Medisystem Pacs (2023), 0 descendants of its own

## Indications for use
ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. ZeeroMED View displays and manages diagnostic quality DICOM images. ZeeroMED View is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. ZeeroMED View is not intended for diagnostic use on mobile devices. Contraindications: The ZeeroMED View is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

Source page: https://510kreport.com/device/K200546
Methodology: https://510kreport.com/methodology