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 record 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
- Product 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
Recent devices under product code KPR
view all- K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
- K260488 — MULTIX Impact; MULTIX Impact C
- K260481 — GC85A
- K260482 — DRE Duo
- K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
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.