Kuvia3D
by 4qimaging, LLC Dba Qmetrics
510(k) K161559
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161559 | Date23 Jun 2016 | 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- Withdrawn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, 1 Oct 2026
Kuvia3D is a medical imaging software device classified as a 3D medical imaging workstation (Product Code: LLZ). It is designed for the display and analysis of DICOM image data, enabling three-dimensional visualization of joint anatomy, particularly knee bones and articular cartilage, to enhance diagnostic and pre-surgical planning.
The device is supplied as a software application for use in radiology and orthopedic settings. It operates on standard computing platforms and is intended for single-use per imaging session, though its sterility or reusability is not applicable as it is non-invasive software. No specific MRI safety classification is stated, and the device requires no special storage conditions beyond standard IT infrastructure. Its regulatory status includes FDA 510(k) clearance under K161559, with a traditional review pathway.
Questions
AI-generated answers, 1 Oct 2026
What is the Kuvia3D imaging workstation designed for?
The Kuvia3D is a software-based 3D medical imaging workstation specifically designed to display and analyze DICOM image data. It creates three-dimensional reconstructions of joint anatomy, particularly focusing on knee bones and articular cartilage. This enhances diagnostic accuracy and aids in pre-surgical planning by providing detailed spatial visualization that is difficult to achieve with traditional 2D imaging.
How is the Kuvia3D supplied and where can it be used?
Kuvia3D is supplied as a software application compatible with standard computing platforms. It is intended for use in radiology departments and orthopedic clinics, where clinicians can leverage its capabilities to review and analyze 3D reconstructions of knee anatomy. Since it is non-invasive software, it does not require physical sterilization or specialized storage beyond typical IT infrastructure.
Is the Kuvia3D software single-use or reusable?
Kuvia3D is designed for single-use per imaging session, meaning it is intended to be utilized once for a specific diagnostic or pre-surgical analysis. However, the software itself can be reinstalled and reused across multiple sessions on the same or different systems, as it is not a consumable or disposable item. Its non-invasive nature means it does not degrade or require replacement after use.
Does Kuvia3D require any special storage conditions?
No, Kuvia3D does not have any special storage requirements beyond those of standard IT infrastructure. Since it is a software application, it only needs to be installed on a compatible computing platform with sufficient hardware resources to run the program. No environmental controls (e.g., temperature, humidity) or physical containment are necessary for its operation or longevity.
What regulatory pathway was followed for Kuvia3D’s FDA clearance?
Kuvia3D received FDA clearance through the traditional 510(k) review pathway, classified under Product Code LLZ (3D medical imaging workstation). The submission was reviewed by the Radiology Advisory Committee (RA) and determined to be substantially equivalent to a predicate device. The clearance number assigned is K161559, issued on June 23, 2016.