📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA product code GKZ record should be consulted for the device's exact cleared indication.
- Available source text identifies the device category as related to TACE devices.
- No more specific FDA-cleared indication is provided in the supplied record.
Clinical Applications
- Use in the TACE-device category as described in the applicable FDA labeling.
- Data management or monitoring associated with a TACE device, if specified in the manufacturer's labeling.
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.
Practical Considerations
- The supplied record does not identify the device's dimensions, component specifications, or compatibility requirements.
- MRI safety has not been established from the available information; consult the original labeling or manufacturer before MRI exposure.
- Use should follow the 1991 FDA clearance, current manufacturer instructions, and applicable institutional protocols.
- The exact role of the device in TACE procedures is unclear from the available record and should be confirmed in the original 510(k) documentation.
- Do not infer catheter, embolic-agent, imaging, or monitoring compatibility without product-specific labeling.
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.