Medipacs
510(k) K040486
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040486 | Date11 Mar 2004 | 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- Withdrawn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, 20 Sep 2026
The Medipacs Picture Archiving and Communications System (PACS) is a Class II medical device classified under 21 CFR 892.2050 as a Picture Archiving and Communications System. It is designed to acquire, store, retrieve, display, and transmit digital medical images and associated patient data for diagnostic and treatment purposes in radiology settings. This system facilitates efficient workflow by enabling radiologists and clinicians to access imaging studies from multiple modalities, including X-ray, CT, and MRI, in a centralized digital format. Its architecture supports seamless integration with existing radiology infrastructure, enhancing image management and reducing reliance on film-based storage.
The Medipacs PACS is supplied as a traditional 510(k) cleared device under FDA clearance (K040486), granted in 2004 following review by the Radiology (RA) Advisory Committee. It is intended for use in radiology departments and operates as a non-sterile, reusable system, requiring proper calibration and maintenance per manufacturer guidelines. The device is not MRI-safe or -compatible, and its storage and operational environment must comply with standard radiology facility protocols. No additional regulatory approvals beyond the 510(k) clearance are referenced in the available data.
Questions
AI-generated answers, 20 Sep 2026
What types of medical imaging studies can the Medipacs PACS handle, and how does it improve workflow efficiency in radiology departments?
The Medipacs PACS is designed to manage digital medical images from multiple modalities, including X-ray, CT, and MRI. It centralizes image storage and retrieval, allowing radiologists and clinicians to quickly access patient studies without relying on physical film archives. This integration streamlines workflow by enabling seamless sharing of diagnostic data across the department, reducing delays and improving collaboration.
Is the Medipacs PACS meant for single-use or repeated use in a clinical setting, and what maintenance is required?
The Medipacs PACS is a reusable system, not intended for single-use. Like all digital infrastructure in radiology, it requires regular calibration and maintenance to ensure accurate image acquisition, storage, and retrieval. The manufacturer provides guidelines for proper upkeep to sustain performance and compliance with radiology facility standards.
What kind of regulatory clearance does the Medipacs PACS hold, and how was the approval process determined?
The Medipacs PACS holds a traditional FDA 510(k) clearance (K040486), granted in 2004 after review by the Radiology (RA) Advisory Committee. The device was deemed *substantially equivalent* to a legally marketed predecessor, meaning its safety and effectiveness were compared to existing PACS systems already on the market. No additional approvals beyond this clearance are referenced.
Can the Medipacs PACS be used in an MRI environment, or are there specific environmental requirements for its operation?
The Medipacs PACS is explicitly *not* MRI-safe or MRI-compatible, so it should not be placed within an MRI scanning room. Its operational environment must adhere to standard radiology facility protocols, including proper ventilation, temperature control, and electrical grounding, to ensure reliable performance and data integrity.
How does the Medipacs PACS integrate with existing radiology infrastructure, and what imaging modalities does it support?
The Medipacs PACS is engineered for seamless integration with current radiology systems, allowing it to acquire, store, and transmit digital images from modalities like X-ray, CT, and MRI. Its architecture enables centralized management of patient data, reducing reliance on film-based storage while maintaining interoperability with existing equipment through standardized communication protocols.