ZeTTA PACS
by Tae Young Soft Co., Ltd. 510(k)
Active
510(k) K241694
Overview
ZeTTA PACS is a Picture Archiving and Communication System (PACS) designed to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and radiographic devices. It functions as a centralized platform for radiology workflows, enabling efficient image management and distribution across healthcare settings.
The system is intended for use in hospitals and diagnostic centers, supplied as a web-based solution with features for reading, dictating, and reporting. It is classified as a Class II X-ray system under FDA 510(k) clearance (K241694), with a decision date of January 31, 2025. No third-party review was involved, and the device is not explicitly stated as single-use or reusable, MRI-safe, or requiring specific sterility conditions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241694 | Date31 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 Tae Young Soft Co., Ltd.
Questions
What is the ZeTTA PACS system designed to do for healthcare facilities?
The ZeTTA PACS is a web-based Picture Archiving and Communication System (PACS) built to centralize and manage medical imaging workflows. It receives, stores, and displays images from DICOM-compliant devices like CT scanners, MRIs, ultrasounds, and X-ray systems. By consolidating these functions, it improves efficiency in radiology departments, enabling faster retrieval, reporting, and distribution of images across hospitals and diagnostic centers.
How is the ZeTTA PACS system supplied, and what type of access does it require?
The ZeTTA PACS is supplied as a web-based solution, meaning it operates through internet-connected devices rather than requiring physical hardware installation. This design allows radiologists and clinicians to access the system remotely, facilitating remote reporting, dictation, and image review from any authorized location with internet access.
Is the ZeTTA PACS system intended for single-use or reusable applications?
The ZeTTA PACS is not explicitly described as single-use or reusable in its specifications. As a software-based PACS system, its functionality relies on ongoing use within healthcare settings, with no physical consumables or disposable components. The system’s design prioritizes scalability and long-term deployment for continuous radiology workflow support.
What types of medical imaging modalities does the ZeTTA PACS support?
The ZeTTA PACS is compatible with DICOM-standard imaging modalities, including computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and radiographic (X-ray) devices. This broad compatibility ensures seamless integration with existing hospital imaging infrastructure, allowing for unified management of diverse image types within a single platform.
Does the ZeTTA PACS require any specific regulatory approvals for use in the U.S.?
The ZeTTA PACS holds FDA 510(k) clearance under the classification of a Class II X-ray system, with the clearance number K241694. This approval indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the U.S. without additional third-party review. The decision was finalized on January 31, 2025.