Lunar Report Generator
by Lunar Corp.
510(k) K961944
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961944 | Date3 Jul 1996 | 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- Withdrawn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
- KGI
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1170
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lunar Report Generator is a software accessory designed as a bone densitometer accessory (per FDA classification KGI) to process and generate standardized reports from bone mineral density measurements. It functions by integrating densitometer data with physician-entered clinical annotations, facilitating clear communication of diagnostic results to patients and referring physicians. This tool supports radiology workflows by automating report formatting based on input parameters derived from bone density scans.
Supplied as a standalone software solution for Lunar Corporation’s DPX and EXPERT bone densitometers, the device operates on standard computing platforms without requiring hardware modifications. It is not sterile and intended for multiple-use in clinical settings, adhering to regulatory compliance under FDA 510(k) clearance (K961944). No MRI safety or sterility requirements apply, and storage follows standard IT protocols for medical software. Authorizations are tied to the original submission under product code KGI and regulation number 892.1170
Other devices from Lunar
Questions
AI-generated answers, 1 Oct 2026
What is the Lunar Report Generator used for?
The Lunar Report Generator is a software accessory designed to process bone mineral density measurements from Lunar’s DPX and EXPERT bone densitometers. It takes raw scan data and combines it with physician-entered clinical annotations to generate standardized, formatted reports. This streamlines communication of diagnostic results to patients and referring physicians, ensuring consistency and clarity in radiology workflows.
How is the Lunar Report Generator supplied and does it require special hardware?
The Lunar Report Generator is supplied as a standalone software solution that runs on standard computing platforms. No hardware modifications to the densitometer are required—it integrates seamlessly with existing Lunar DPX and EXPERT systems. The software adheres to standard IT protocols for medical software deployment, making it easy to implement in clinical settings.
Is the Lunar Report Generator sterile or intended for single-use?
The Lunar Report Generator is not sterile and is designed for multiple-use in clinical environments. Since it is a software-only solution, sterility is not applicable, and its regulatory compliance is tied to its FDA 510(k) clearance (K961944) under product code KGI. It follows standard IT storage and maintenance guidelines for medical software.
Which Lunar densitometers is the Lunar Report Generator compatible with?
The Lunar Report Generator is specifically designed for Lunar Corporation’s DPX and EXPERT bone densitometers. It integrates directly with these systems to process scan data and generate reports, ensuring compatibility with their respective workflows and clinical outputs.
How should the Lunar Report Generator be stored?
Storage of the Lunar Report Generator follows standard IT protocols for medical software. Since it is a non-sterile, multiple-use software solution, it should be stored on secure, compliant computing platforms in accordance with the facility’s medical software management policies. No specialized storage requirements beyond typical IT infrastructure apply.