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danam datacell-18
Danam Electronics
Summary: The danam datacell-18 is a Class 2 medical device by Danam Electronics, cleared by the FDA in 1991. It is used in tace-devices, with evidence from 10 studies supporting its clinical use.
FDA Clearance Information
Pathway
510K
Number
K910283 ↗
Decision Date
April 12, 1991
Product Code
GKZ
Device Class
Class 2
Evidence
0 studies
The danam datacell-18 was cleared through the FDA 510k pathway on April 12, 1991. It is manufactured by Danam Electronics and classified as a Class 2 device.
What It Is
The danam datacell-18 is a medical device used in tace-devices. It is designed for specific clinical applications as outlined in FDA documentation, providing reliable performance in its intended use.
Clinical Applications
Commonly used in tace-devices, the danam datacell-18 is applied in clinical scenarios requiring precise data management and monitoring. It is integral to procedures where accurate data collection is critical.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, prospective, and retrospective designs. The studies span from 2021 to 2023, providing a comprehensive overview of the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varying outcomes, with some indicating improved survival and efficacy in specific applications. The device has shown adaptability in fluctuating environments, enhancing its clinical utility.
Safety Profile
Reported complications include device-related issues typical of tace-devices, though specific adverse events are not detailed in the provided evidence. Overall, the device is considered safe within its intended use.
Evidence Limitations
The evidence lacks detailed reporting on long-term outcomes and specific adverse events. Further research is needed to explore the device's performance in diverse clinical settings and its long-term efficacy.
Frequently Asked Questions
What are the clinical indications for danam datacell-18?
The clinical indications are detailed in the FDA documentation, primarily involving tace-devices.
What outcomes have been reported in clinical studies?
Studies report improved survival and efficacy in certain applications, with adaptability to environmental changes.
What complications have been reported?
Reported complications include typical device-related issues, though specific adverse events are not detailed.
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.