# K241694: ZeTTA PACS

- Pathway: 510(k) (Traditional)
- Applicant: Tae Young Soft Co., Ltd.
- Decided: Jan 31, 2025 after 233 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: 6 generations back to K942120 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172803: Infinitt PACS 7.0, Infinitt Healthcare Co., Ltd. (2017) Summary page 6.

## Indications for use
ZeTTA PACS is intended for use in hospitals and diagnostic centers as a PACS to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices. The system enables healthcare professionals to securely access and analyze diagnostic images over hospital networks. Typical users of ZeTTA PACS include trained professionals such as physicians, radiologists, and medical technicians. For mammography, only preprocessed DICOM for-presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA.

Source page: https://510kreport.com/device/K241694
Methodology: https://510kreport.com/methodology