Connect Imaging PACS
510(k) K061972
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061972 | Date18 Sep 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Connect Imaging PACS is a Picture Archiving and Communication System (PACS) designed for radiology departments. It facilitates the storage, retrieval, distribution, and presentation of medical images and patient data in digital format, enabling efficient workflow and collaboration among healthcare providers. This system integrates with existing imaging modalities to ensure seamless access to diagnostic information, supporting clinical decision-making and patient care.
Supplied as software-based infrastructure, the Connect Imaging PACS is intended for use in radiology settings and is cleared for commercial distribution in the United States under an FDA 510(k) submission (K061972). The system is classified as a Class II medical device and is not single-use; it requires installation and maintenance by authorized personnel. No specific sterility or MRI safety information is provided, and the device operates as a reusable digital solution. Storage and operational requirements are defined by the manufacturer’s technical specifications.
Other devices from Connect Imaging, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Connect Imaging PACS used for?
The Connect Imaging PACS is a digital Picture Archiving and Communication System designed specifically for radiology departments. It enables secure storage, efficient retrieval, and seamless distribution of medical images and patient data, ensuring healthcare providers have instant access to diagnostic information. This supports faster clinical decision-making and improves patient care by centralizing imaging workflows.
How is the Connect Imaging PACS supplied and installed?
The Connect Imaging PACS is supplied as a software-based infrastructure and requires professional installation by authorized personnel. It is not a standalone hardware device but integrates with existing imaging modalities within a radiology setting. The system must be set up according to the manufacturer’s technical specifications to ensure proper functionality and compliance.
Is the Connect Imaging PACS single-use or reusable?
The Connect Imaging PACS is a reusable digital solution and is not intended for single-use. As a software-based system, it operates continuously within a radiology environment, requiring regular maintenance and updates by authorized personnel to sustain performance and security.
Does the Connect Imaging PACS require sterility or MRI safety considerations?
The Connect Imaging PACS does not involve physical materials that require sterility, as it is a software-based system. Additionally, there are no specific MRI safety considerations provided for this device, as it operates independently of magnetic resonance imaging environments. Always verify compatibility with your facility’s imaging infrastructure.
What regulatory clearance does the Connect Imaging PACS hold?
The Connect Imaging PACS holds FDA 510(k) clearance under the reference number K061972, classified as a Class II medical device. This clearance confirms its substantial equivalence to a predicate device and allows commercial distribution in the United States. The system was reviewed by the Radiology (RA) Advisory Committee in 2006.