Z-Motion Digital Diagnostic X-Ray System
510(k) K102680
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102680 | Date22 Oct 2010 | 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- Withdrawn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
- KPR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Z-Motion Digital Diagnostic X-Ray System is a stationary, motorized, single-detector radiographic device designed for general-purpose diagnostic imaging. It provides high-resolution digital X-ray imaging for a range of medical applications, including musculoskeletal, thoracic, and abdominal assessments. Its free-standing design and versatile configuration accommodate various patient positions and imaging requirements in clinical settings.
This system is supplied as a reusable, non-sterile medical device intended for use in radiology departments. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance through a traditional review pathway. The system is not MRI-compatible and requires proper storage in a controlled environment to maintain operational integrity. Multiple model and registration numbers are associated with its regulatory submissions.
Questions
AI-generated answers, 19 Sep 2026
What types of medical imaging procedures is the Z-Motion Digital Diagnostic X-Ray System designed to support in clinical settings?
The Z-Motion Digital Diagnostic X-Ray System is specifically designed for general-purpose diagnostic imaging, covering a broad range of applications including musculoskeletal assessments (e.g., bones, joints), thoracic imaging (e.g., chest X-rays), and abdominal evaluations. Its motorized, stationary design and versatile configuration allow for flexible patient positioning, making it suitable for diverse clinical needs in radiology departments.
Is the Z-Motion Digital Diagnostic X-Ray System intended for single-use or reusable applications, and what does this mean for maintenance?
The Z-Motion system is supplied as a reusable, non-sterile medical device, meaning it is engineered for repeated use in clinical environments. This design implies that proper cleaning, disinfection, and maintenance protocols must be followed to ensure operational integrity and patient safety between uses. The manufacturer’s instructions should be consulted for specific care guidelines.
How should the Z-Motion Digital Diagnostic X-Ray System be stored to preserve its functionality and safety?
The system requires storage in a controlled environment to maintain its operational integrity. This likely includes protection from extreme temperatures, humidity, or physical damage. Since it is not MRI-compatible, it should also be stored away from electromagnetic interference sources. Follow the manufacturer’s guidelines for optimal storage conditions to ensure longevity and reliability.
What regulatory pathway was used for FDA clearance of the Z-Motion Digital Diagnostic X-Ray System, and what does this imply for its use?
The Z-Motion system received FDA clearance through a traditional 510(k) review pathway, determined to be substantially equivalent to a predicate device. This means the FDA evaluated it against an existing approved or cleared device in the same category (KPR product code, Class II) to ensure safety and effectiveness. Clinicians can rely on this pathway as evidence of regulatory scrutiny, though local institutional policies may still apply for integration into workflows.
Does the Z-Motion Digital Diagnostic X-Ray System come with multiple model or registration numbers, and why might this matter?
Yes, the system is associated with multiple registration and FEI numbers (e.g., 3003768277, 3009715136, etc.) due to variations in its design, software updates, or regulatory submissions. These numbers may reflect different configurations or compliance batches. For procurement or maintenance, verifying the correct model/registration number ensures compatibility with spare parts, software updates, or warranty services from the manufacturer.