| K-number | K253446 |
| Device name | AeroDR TX c02 |
| Applicant | Dk Medical Systems Co., Ltd. |
| Product code | KPR |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1680 |
The AeroDR TX c02 is a stationary X-ray system designed to obtain radiographic images of various anatomical parts of the human body in pediatric and adult patients within a clinical environment. It is not intended for mammography, angiography, interventional procedures, or fluoroscopy use.
The device differs from its predicate (INNOVISION-EXII, K242119) only in non-critical components: alternate X-ray tube (E7884X), alternate collimator (BL-80), patient table (PT5-G1 K), X-ray detector stand (WS5-G1 K), and ceiling-suspended tube support (CS5-G1 K). The X-ray detectors, software, and cybersecurity characteristics remain unchanged from the predicate.
Conformance to IEC 60601-1 (Edition 3.2, 2020-08), IEC 60601-1-2 (Edition 4.1, 2020-09), IEC 60601-1-3 (Edition 2.2, 2021-01), IEC 60601-2-28 (Edition 3.0, 2017-06), and IEC 60601-2-54 (Edition 2.0, 2022-09) was demonstrated through EMC and safety testing.
The differences in hardware components do not affect X-ray image generation, and testing confirmed no new safety or effectiveness concerns arise from these design changes. The software, cybersecurity, and image quality remain identical to the predicate device, making AeroDR TX c02 substantially equivalent to INNOVISION-EXII.
View the full FDA submission: accessdata.fda.gov