VIEW Image Processing and Viewing Station
510(k) K864854
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864854 | Date26 Feb 1987 | 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- Withdrawn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
- Full name
- View(Tm) Image Processing and Viewing Station
- 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 VIEW Image Processing and Viewing Station is a medical imaging device classified as a Radiology Workstation (Product Code: LLZ). It is designed for processing, enhancing, and displaying radiographic images, enabling radiologists and medical professionals to interpret and analyze X-ray and other imaging data with improved clarity and efficiency. This system supports diagnostic workflows by providing tools for image manipulation, measurement, and annotation, facilitating accurate medical assessments. Its functionality aligns with traditional radiology viewing stations, ensuring compatibility with existing diagnostic protocols.
This device is supplied as a standalone workstation for use in radiology departments, hospitals, or clinical imaging centers. It operates as a reusable, non-sterile system, requiring proper calibration and maintenance to ensure consistent image quality. The VIEW Station does not contain MRI-compatible components and must be used in environments free from electromagnetic interference. Authorized for use in the United States under FDA 510(k) clearance (K864854), it adheres to regulatory standards for radiology equipment, ensuring compliance with safety and performance requirements. Storage and handling follow standard IT and medical imaging protocols to preserve functionality.
Other devices from Virtual Imaging, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the VIEW Image Processing and Viewing Station used for?
The VIEW Image Processing and Viewing Station is designed specifically for processing, enhancing, and displaying radiographic images, such as X-rays. It provides radiologists and medical professionals with advanced tools for image manipulation, measurement, and annotation to improve diagnostic accuracy and efficiency in radiology departments, hospitals, or clinical imaging centers.
Is the VIEW Station a single-use or reusable device?
The VIEW Image Processing and Viewing Station is a reusable system. It is not sterile and requires proper calibration and maintenance to ensure consistent performance and image quality. Regular upkeep is essential to sustain its functionality over repeated use.
What type of environment is required for the VIEW Station?
The VIEW Station must be used in environments free from electromagnetic interference, as it is not MRI-compatible. It is intended for radiology departments, hospitals, or clinical imaging centers where standard IT and medical imaging protocols are followed for storage and handling.
How is the VIEW Station supplied?
The VIEW Image Processing and Viewing Station is supplied as a standalone workstation. It is not packaged for individual procedures or patients but is intended for integration into existing radiology workflows as a dedicated imaging analysis tool.
What regulatory approval does the VIEW Station hold?
The VIEW Image Processing and Viewing Station holds FDA 510(k) clearance (K864854) in the United States, demonstrating compliance with regulatory standards for radiology equipment. This clearance confirms its substantial equivalence to a predicate device and adherence to safety and performance requirements.