← Product Code [KGI](/productcode/KGI) · K961944 # LUNAR REPORT GENERATOR (K961944) _Lunar Corp. · KGI · Jul 3, 1996 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K961944 ## Device Facts - **Applicant:** Lunar Corp. - **Product Code:** [KGI](/productcode/KGI.md) - **Decision Date:** Jul 3, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1170 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Indications for Use The LUNAR Report Generator is provided as a software accessory to Lunar Corporation DPX and EXPERT bone mineral densitometers. The Report Generator assists the physician in communicating densitometer results to the patient and the patient’s referring physician. ## Device Story Software accessory for Lunar DPX/EXPERT bone densitometers; inputs densitometer data and physician-entered text; provides word processing interface for report generation; operated by physicians in clinical settings; output is a printed report summarizing densitometry findings; device does not interpret data, diagnose, assess fracture risk, or recommend treatment; physician maintains absolute control over report content; densitometer data remains unmodified. ## Clinical Evidence No clinical data; bench testing only. Device is a software accessory that does not perform automated analysis or clinical interpretation. ## Technological Characteristics Software accessory; operates on Lunar DPX and EXPERT bone densitometer platforms; provides word processing functionality; no automated analysis or data modification; standalone software module. ## Regulatory Identification A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Predicate Devices - The OsteoReport ([K934040](/device/K934040.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} LUNAR JUL - 3 1996 K961944 313 W BELTLINE HIGHWAY MADISON, WI 53713 (608) 274-2663 ## 9.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(C). Re: 510(k) Pre-market Notification Contact Person: Gary Syring LUNAR Corporation 313 West Beltline Highway Madison, WI 53713 Phone: (608) 274-2663 Fax: (608) 274-0853 Date: May 16, 1996 Device Name: LUNAR Report Generator Common Name: Report Generator Trade Name: Lunar Corporation Report Generator Classification Name: 21 CFR 892.1170, Bone Densitometer Predicate Device: K 93 4040 The OsteoReport ## 9.1 DESCRIPTION OF THE DEVICE: The LUNAR Report Generator is provided as a software accessory to Lunar Corporation DPX and EXPERT bone mineral densitometers. The Report Generator assists the physician in communicating densitometer results to the patient and the patient’s referring physician. The reports are generated with data received from the densitometer and physician comments. The Report Generator includes a dedicated word processing program so the physician may add comments to the data provided. The densitometer data is not modified by the Report Generator. The report is used under the complete and absolute control of the physician. The report does not: - interpret or advise the physician, - diagnose osteoporosis, - assign a level of risk for fracture based upon bone density, - make treatment recommendations. RPTG510K.DOC Page 13 {1} # 9.2 CONCLUSION The LUNAR Report Generator is a safe device. All reports are generated under the supervision of the physician. The Report Generator does not perform any automated analysis of bone mineral densitometer data or provide any new or modified output. ![img-0.jpeg](img-0.jpeg) Gary Syring Printed Name Director, Regulatory Affairs Title 16 May '96 Date RPTG510K.DOC --- **Source:** [https://fda-staging.innolitics.com/device/K961944](https://fda-staging.innolitics.com/device/K961944) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com