AeroDR TX c02— 510(k) K253446
Substantially EquivalentDk Medical Systems Co., Ltd.
FDA 510(k) clearance K253446 for AeroDR TX c02, Substantially Equivalent on 2026-04-10. Applicant: Dk Medical Systems Co., Ltd.. Device class: 2.
Summary
AeroDR TX c02 is filed under KPR, stationary X-ray systems, the code for fixed general radiography equipment. AeroDR is best known as Konica Minolta's digital radiography brand. The record doesn't explain how this Korean applicant's system relates to that line, and it doesn't describe the configuration.
Class II, 21 CFR 892.1680. The Radiology panel reviewed it as a Traditional 510(k).
DK Medical Systems filed from Pyeongtaek, South Korea. Review took 190 days (October 2, 2025 to April 10, 2026).
Clearance details
- Applicant
- Dk Medical Systems Co., Ltd.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pyeongtaek-Si, KR
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More clearances from Dk Medical Systems Co., Ltd.
view allAdverse 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.