510(k) K253446— AeroDR TX c02
Substantially EquivalentDk Medical Systems Co., Ltd.
Summary
The AeroDR TX c02 is a digital radiography detector — product code KPR covers solid-state flat-panel X-ray detectors used in general radiography. The "c02" version suggests an iteration within Dk Medical Systems' AeroDR line.
Radiology panel, Traditional 510(k). Detector clearances tend to be mechanical and signal-path comparisons against predicate detectors — the substantial equivalence argument is usually straightforward for iterations within a product family. Review clocks on KPR typically run 4-6 months.
Dk Medical Systems is a Korean applicant based in Pyeongtaek. Six-month clock here. Digital detectors from Korean and Japanese manufacturers dominate the KPR category by volume.
Clearance details
- Applicant
- Dk Medical Systems Co., Ltd.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pyeongtaek-Si, KR
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.