Identifiers
- 510(k) Number
- K253446 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AeroDR TX c02 is a stationary X-ray system used in radiology to capture X-ray images. It is classified as a Class II medical device under regulation number 892.1680 with product code KPR.
The device received FDA 510(k) clearance (K253446) on April 10, 2026, following a traditional review process. It is manufactured by Dk Medical Systems Co., Ltd. and is intended for use in radiology settings to produce diagnostic images for evaluating medical conditions.
Frequently asked questions
What is the AeroDR TX c02 used for?
The AeroDR TX c02 is a stationary X-ray system used in radiology to capture X-ray images for diagnostic purposes, as stated in its description for producing images to evaluate medical conditions.
How is the AeroDR TX c02 supplied or configured for use?
The AeroDR TX c02 is a stationary system, meaning it is designed for fixed installation in radiology settings and is not portable or mobile; it is supplied as a complete unit for fixed use in clinical environments.
Is the AeroDR TX c02 intended for single-use or reuse?
The AeroDR TX c02 is a stationary X-ray system designed for repeated use over time in radiology departments; it is not a single-use device but rather a durable medical equipment system intended for long-term operation.
What regulatory pathway was used for the AeroDR TX c02?
The AeroDR TX c02 received FDA 510(k) clearance through a traditional review process, as indicated by the clearance_type field and the K253446 number, showing it was found substantially equivalent to a predicate device.
What are the key identifiers for the AeroDR TX c02?
The AeroDR TX c02 is identified by its device name, FDA 510(k) number K253446, product code KPR, regulation number 892.1680, and manufacturer Dk Medical Systems Co., Ltd., which distinguish it from other systems.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AeroDR TX c02 (K253446) — FDA 510 (k) | Innolitics, K253446 FDA 510 (k) - AeroDR TX c02, AeroDR TX c02 | FDA Radiology AI Device - radaislice.com, AeroDR TX c02 510 (k) K253446 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253446 | Class II | Active |
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Manufacturer
- Manufacturer
- Dk Medical Systems Co., Ltd.
Sources (1)
- FDA 510(k) K253446 24 fields · synced Sep 24, 2026