Insight Enhanced DRF Digital Imaging System— 510(k) K200396
Substantially EquivalentImaging Engineering, LLC
FDA 510(k) clearance K200396 for Insight Enhanced DRF Digital Imaging System, Substantially Equivalent on 2020-03-06. Applicant: Imaging Engineering, LLC.
Clearance details
- Applicant
- Imaging Engineering, LLC
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cape Coral, FL, US
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.