Chondral Quant
by Siemens Medical Soultions USA, Inc.
510(k) K231351
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231351 | Date13 Jul 2023 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Chondral Quant is a radiological image processing system designed for quantitative analysis of cartilage and joint structures in X-ray imaging. It falls under the classification of advanced image processing tools, specifically for evaluating chondral (cartilage) integrity and pathology within musculoskeletal radiology.
This device is used in radiology settings for post-processing and analysis of X-ray images, enabling clinicians to assess cartilage thickness, defects, and degenerative changes. Supplied as software integrated with radiological systems, it operates under FDA 510(k) clearance (K231351) and is classified under product code LLZ. No sterility or single-use requirements are specified, as it is intended for reusable software deployment in MRI-safe environments.
Other devices from Siemens Medical Soultions USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical applications does the Chondral Quant software support in radiology settings?
The Chondral Quant is specifically designed for quantitative analysis of cartilage and joint structures in X-ray imaging. Clinicians use it to evaluate cartilage thickness, identify defects, and assess degenerative changes in musculoskeletal radiology. It helps in post-processing X-ray images to provide detailed insights into chondral integrity, aiding in the diagnosis and monitoring of joint pathologies.
How is the Chondral Quant system supplied and deployed in a clinical environment?
The Chondral Quant is supplied as software integrated with radiological systems, meaning it is not a standalone physical device but rather a digital tool that runs on existing imaging infrastructure. Since it is software-based, there are no sterility or single-use requirements—it is intended for reusable deployment in MRI-safe environments, ensuring compatibility with standard radiology workflows.
Is the Chondral Quant system compatible with any specific imaging modalities, and how does it integrate with existing systems?
The Chondral Quant is explicitly designed for use with X-ray imaging, enabling quantitative analysis of cartilage and joint structures captured via this modality. As it is software-based, integration occurs within radiological systems already in place, allowing clinicians to leverage post-processing capabilities directly on their existing X-ray images without requiring additional hardware.
What regulatory pathway was followed for the Chondral Quant, and what does this mean for its use in clinical practice?
The Chondral Quant received FDA clearance through a traditional 510(k) pathway (K231351), with a decision classification of *Substantially Equivalent* under product code LLZ. This means the device was determined to be comparable to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness. Clinicians can rely on its compliance with FDA requirements for advanced image processing tools in musculoskeletal radiology.