Infinitt PACS 7.0
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- INFINITT PACS, INFINITT G3, INFINITT Mammo FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- INFINITT PACS EUDAMED
- Model / Reference
- 502 EUDAMEDINFINITT PACS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809278790055 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809278790055 EUDAMED
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Infinitt PACS 7.0 is a Picture Archiving and Communication System (PACS) designed for the digital storage, retrieval, and distribution of medical imaging data. It facilitates seamless integration with radiology workflows, enabling efficient management of diagnostic images such as X-rays, MRIs, CT scans, and ultrasounds in healthcare settings.
This system is supplied as a software solution, intended for use in radiology departments and imaging centers. It operates on a networked infrastructure, requiring compatible hardware and IT support for deployment. The device is classified under the MDD and holds FDA 510(k) clearance (K172803) as substantially equivalent to a predicate device, adhering to regulatory standards for medical imaging software.
Frequently asked questions
What types of medical imaging data can the Infinitt PACS 7.0 handle, and how does it integrate with existing radiology workflows?
The Infinitt PACS 7.0 is designed to manage digital medical imaging data such as X-rays, MRIs, CT scans, and ultrasounds. It integrates seamlessly with radiology workflows by providing a centralized platform for storing, retrieving, and distributing these images across a networked infrastructure. This ensures efficient management and quick access to diagnostic images, streamlining the radiology department’s operations.
Is the Infinitt PACS 7.0 a standalone software solution, and what hardware or IT support is required for deployment?
Yes, the Infinitt PACS 7.0 is supplied exclusively as a software solution and is not a physical device. To deploy it, compatible hardware and IT infrastructure are required, as it operates within a networked environment. This means your facility will need existing servers, workstations, and IT support to ensure proper installation, configuration, and ongoing maintenance of the system.
How does the Infinitt PACS 7.0 ensure compliance with regulatory standards, and what is its regulatory pathway?
The Infinitt PACS 7.0 adheres to regulatory standards through its FDA 510(k) clearance (K172803), which classifies it as substantially equivalent to a predicate device under the FDA’s traditional review pathway. Additionally, it complies with the Medical Device Directive (MDD) in its original market. This ensures the software meets necessary safety, performance, and quality requirements for use in healthcare settings.
What kind of healthcare settings is the Infinitt PACS 7.0 intended for, and how does it support radiology departments?
The Infinitt PACS 7.0 is specifically designed for radiology departments and imaging centers within healthcare facilities. It supports these settings by providing a robust digital platform for storing, organizing, and sharing medical imaging data, which helps radiologists and clinicians access diagnostic images quickly and efficiently. This reduces manual workflow bottlenecks and improves overall diagnostic workflow efficiency.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172803 | Class II | Active |
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Manufacturer
- Manufacturer
- Infinitt Healthcare Co., Ltd.
Sources (3)
- FDA 510(k) K172803 24 fields · synced Sep 18, 2026
- FDA UDI 67ca6c6f-8cc3-412a-8971-daff9bc0cee1 33 fields · synced May 30, 2026
- EUDAMED e1cf0399-8af1-47e4-8c52-d44fcdd56ff0 61 fields · synced Jul 30, 2026