APX-24 Portable X-ray System
510(k) K220678
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220678 | Date31 Mar 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The APX-24 Portable X-ray System is a mobile radiographic device designed for generating X-ray images. It falls under the classification of a portable X-ray system, enabling real-time imaging in various clinical settings where fixed equipment is impractical. The system is intended for diagnostic radiography, allowing healthcare providers to capture high-quality images of internal structures for assessment.
This device is supplied as a reusable medical instrument, intended for use in radiology departments, emergency settings, and mobile environments. It is not sterile and requires proper cleaning and maintenance between uses. The APX-24 is classified as a Class II device under FDA regulations and holds a 510(k) clearance, indicating it has been deemed substantially equivalent to a legally marketed predicate device. The system operates within specified voltage and power ranges and must be stored in a controlled environment to ensure functionality and safety.
Questions
AI-generated answers, 1 Oct 2026
What is the APX-24 Portable X-ray System used for?
The APX-24 Portable X-ray System is designed for diagnostic radiography, enabling healthcare providers to capture high-quality images of internal structures in clinical settings where fixed X-ray equipment is impractical. This includes emergency departments, mobile units, and other environments where portability and real-time imaging are essential.
Is the APX-24 Portable X-ray System single-use or reusable?
The APX-24 Portable X-ray System is a reusable medical instrument. It is not intended for single-use and requires proper cleaning and maintenance between uses to ensure functionality and safety. Regular maintenance is critical to prevent contamination and ensure consistent performance.
Does the APX-24 Portable X-ray System come sterile?
No, the APX-24 Portable X-ray System is not supplied sterile. Since it is a reusable device, it must be cleaned and maintained according to manufacturer guidelines to prevent cross-contamination and ensure safe use across multiple patients.
What storage conditions are required for the APX-24 Portable X-ray System?
The APX-24 Portable X-ray System must be stored in a controlled environment to maintain its functionality and safety. This includes protection from physical damage, extreme temperatures, and moisture. Proper storage also ensures compliance with manufacturer recommendations and regulatory requirements for medical devices.
What regulatory clearance does the APX-24 Portable X-ray System hold?
The APX-24 Portable X-ray System holds an FDA 510(k) clearance, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This clearance is part of the regulatory process for Class II medical devices, ensuring it meets safety and effectiveness standards for diagnostic radiography.