Bone VCAR (BVCAR)
by GE Medical Systems SCS France EUDAMED510(k)
510(k) K183204 Product code JAK
Overview
Bone VCAR (BVCAR) is a deep learning-based software analysis package designed for automated spine visualization in computed tomography (CT) imaging. It enhances radiologic assessment by generating automated spine labeling, 3D tracing, and oblique/straightened reformats to improve diagnostic clarity and workflow efficiency.
This software is intended for use within CT imaging systems to assist radiologists in spine analysis. Supplied as part of a radiology workflow, it operates as a reusable, non-sterile tool with no specific MRI safety classification. Authorized under FDA 510(k) clearance (K183204) and MDR compliance, Bone VCAR is integrated into GE Medical Systems’ imaging solutions for spine reconstruction and review.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK183204 | Date8 Apr 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from GE Medical Systems SCS
Questions
What specific clinical tasks does Bone VCAR (BVCAR) automate in spine imaging, and how does it improve workflow efficiency for radiologists?
Bone VCAR automates spine visualization in CT imaging by generating automated spine labeling, 3D tracing, and creating oblique/straightened reformats. These features enhance diagnostic clarity by providing clearer anatomical views and streamline workflow efficiency for radiologists by reducing manual tracing and reformatting time.
Is Bone VCAR a single-use or reusable tool, and what are its sterility and MRI safety considerations?
Bone VCAR is a reusable, non-sterile software tool designed for integration into CT imaging systems. Since it is software-based and not a physical implantable or disposable device, it does not require sterility or have an MRI safety classification.
How is Bone VCAR integrated into existing imaging systems, and what GE Medical Systems platforms does it support?
Bone VCAR is designed as part of GE Medical Systems’ imaging solutions and is intended for use within their CT systems to assist in spine reconstruction and review. It operates as a software package integrated into the radiology workflow, enhancing automated spine visualization.
What regulatory pathways does Bone VCAR follow, and what does the FDA 510(k) clearance (K183204) indicate about its equivalence?
Bone VCAR is authorized under FDA 510(k) clearance (K183204) with a decision code of SESE (Substantially Equivalent, Special), indicating it has been determined to be substantially equivalent to a legally marketed predicate device in terms of technology and performance. It also complies with the EU Medical Device Regulation (MDR).
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K183204
- EUDAMED