# K221796: Cyware 4H and Cysart 4H

- Pathway: 510(k) (Traditional)
- Applicant: Abys Medical
- Decided: Dec 30, 2022 after 192 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: 14 generations back to K913770 (1991). 168 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203195: Simpleware ScanIP Medical, Synopsys (Northern Europe), Ltd. (2021) Summary page 5.
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 5.
- K171754: NovaPACS, Novarad Corporation (2017) Summary page 5.
- K210072: HOLOSCOPE-i, Real View Imaging, Ltd. (2021) Summary page 5.
- K172418: OpenSight, Novarad Corporation (2018) Summary page 5.

## Most influential descendants
- K243069: Lumys (V1) (2025), 0 descendants of its own

## Indications for use
Abys® Medical Cysware® 4H is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Abys® Medical Cysware® 4H is also intended as pre-operative software for surgical planning assistance. Abys® Medical Cysware® 4H is intended to be used by clinician with appropriate clinical judgement. Abys® Medical Cysart® 4H is a medical display intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from CT scan source. The device is intended to provide visual information to be used by clinician with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. Abys® Medical Cysart® 4H is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Abys® Medical Cysart® 4H is intended to be used as a reference display for consultation to assist the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K221796
Methodology: https://510kreport.com/methodology