ASPIRE Bellus II
by Fujifilm Medical Systems U.S.A, Inc. 510(k)
Active
510(k) K171463
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171463 | Date29 Sep 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
The ASPIRE Bellus II is a medical imaging software system designed for radiologists and trained medical imaging professionals. It provides tools to enhance the interpretation and reporting of mammographic images, incorporating tailored reading protocols to improve diagnostic accuracy. The software supports structured workflows, including side-by-side comparison of current and prior studies, to facilitate comprehensive analysis. Its classification aligns with Class II X-ray imaging devices under regulatory frameworks.
ASPIRE Bellus II is supplied as a software application integrated with imaging systems, intended for use in radiology departments. It operates on compatible workstations and requires no physical sterilisation or single-use considerations, as it is a reusable digital tool. The system adheres to MRI safety standards for its intended environment, though its use is restricted to non-MRI settings. Authorised under FDA 510(k) clearance (K171463), it is regulated as a diagnostic imaging aid for mammography interpretation.
Other devices from Fujifilm Medical System U.S.A., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ASPIRE Bellus II used for?
The ASPIRE Bellus II is a software system designed specifically for radiologists and trained imaging professionals to improve the interpretation and reporting of mammographic images. It includes tailored reading protocols and tools for side-by-side comparison of current and prior studies, helping to streamline analysis and enhance diagnostic accuracy in mammography.
How is the ASPIRE Bellus II supplied and does it require sterilization?
The ASPIRE Bellus II is supplied as a software application integrated with imaging systems, intended for use on compatible radiology workstations. Since it is a digital tool, no physical sterilization is required. It is a reusable system, not a single-use device, and operates within non-MRI environments while adhering to MRI safety standards for its intended setting.
Is the ASPIRE Bellus II approved for use in MRI rooms?
No, the ASPIRE Bellus II is explicitly designed for use in non-MRI settings. While it adheres to MRI safety standards for its intended environment, it is not approved or intended for deployment within MRI rooms or areas where magnetic resonance imaging equipment is operational.
What regulatory clearance does the ASPIRE Bellus II hold?
The ASPIRE Bellus II holds FDA 510(k) clearance under the reference number K171463. This clearance classifies it as a substantially equivalent diagnostic imaging aid for mammography interpretation, aligning with Class II X-ray imaging devices under regulatory frameworks.
Does the ASPIRE Bellus II support structured workflows for radiologists?
Yes, the ASPIRE Bellus II is designed to support structured workflows tailored for radiologists. It provides features such as side-by-side comparison of current and prior mammographic studies, which helps facilitate comprehensive analysis and improves the efficiency and accuracy of diagnostic reporting.