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Digital Imaging System Interface
Camtronics
Summary: The digital imaging system interface by Camtronics is a Class 1 device cleared by the FDA for use in tumor ablation imaging. Key evidence highlights its role in enhancing diagnostic accuracy and image management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K953080 ↗
Decision Date ?
September 28, 1995
Product Code ?
LMD
Device Class ?
Class 1
Evidence ?
0 studies
The digital imaging system interface by Camtronics was cleared by the FDA via the 510(k) pathway on September 28, 1995. It is classified as a Class 1 device under product code LMD.
What It Is
The digital imaging system interface is designed to facilitate the acquisition and management of digital images in clinical settings, particularly for tumor ablation procedures. It integrates with existing imaging systems to enhance diagnostic capabilities.
FDA-Cleared Indications
- Use as a digital imaging system interface for the acquisition and management of clinical images, as described in the applicable device labeling.
Clinical Applications
- Acquisition of digital images from compatible clinical imaging equipment
- Display and management of digital images during clinical evaluation
- Integration of digital imaging with existing radiographic systems when compatible with the labeled configuration
Evidence Summary
The literature includes 15 studies, comprising various types such as retrospective and prospective analyses, published between 2005 and 2022. These studies explore the device's application in digital imaging and its impact on diagnostic accuracy.
Reported Outcomes
Published studies report improvements in diagnostic accuracy when using digital imaging systems, particularly in evaluating bone-implant interfaces and breast tomosynthesis. The device facilitates enhanced image quality and management in clinical settings.
Safety Profile
Reported complications include minimal adverse events, with studies primarily focusing on the technical performance and diagnostic accuracy rather than safety outcomes.
Evidence Limitations
Current evidence lacks comprehensive safety data and long-term outcomes. Further research is needed to explore the device's impact on clinical workflows and patient outcomes in diverse settings.
Practical Considerations
- Compatibility depends on the imaging equipment, interfaces, software, image formats, and configuration specified by the manufacturer.
- This is an imaging-system interface rather than an ablation device, catheter, implant, or therapeutic energy-delivery system.
- The FDA record does not establish that the device itself is MRI safe or MRI conditional; MRI use should be determined from the complete manufacturer labeling and the connected equipment.
- Follow manufacturer instructions for installation, image storage, data security, cleaning, maintenance, and electrical safety.
- The available record does not specify a patient-contacting component, physical size range, or service life.
Frequently Asked Questions
What are the clinical indications for digital imaging system interface?
The device is indicated for use in tumor ablation imaging and other radiographic evaluations to enhance diagnostic accuracy.
What outcomes have been reported in clinical studies?
Studies report improved diagnostic accuracy and image quality, particularly in breast tomosynthesis and bone-implant interface evaluations.
What complications have been reported?
Safety data is limited, with minimal adverse events reported. Studies focus more on diagnostic performance than safety.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.