← Product Code [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI) · K964307 # EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS (K964307) _Lunar Corp. · KGI · Apr 16, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K964307 ## Device Facts - **Applicant:** Lunar Corp. - **Product Code:** [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI.md) - **Decision Date:** Apr 16, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1170 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator’s Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials. ## Device Story Device consists of expanded reference database for LUNAR DPX series bone densitometers; provides comparative BMD data for clinicians. Input: patient BMD measurements from AP Spine, Lateral Spine, Proximal Femur, Total Body, or Radius Shaft. Transformation: software compares patient BMD against tabulated reference values for white adults (U.S./Northern Europe). Output: comparative BMD statistics displayed to clinician. Used in clinical settings by physicians/technicians to assist in bone density evaluation. Benefits: provides broader normative data for clinical interpretation of bone density scans. ## Clinical Evidence No clinical data; submission consists of expanded normative reference values derived from published literature for comparative purposes. ## Technological Characteristics Software-based reference database update for existing DPX series bone densitometers. No changes to hardware, sensing principles, or energy sources. ## 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 - Modified DPX Bone Densitometer (K89021) ## 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} APR 16 1997 K964307 LUNAR 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). | Contact Person: | Kenneth D. Buroker LUNAR Corporation 313 West Beltline Highway Madison, WI 53713 | | --- | --- | | Phone: | (608) 288-6460 | | Fax: | (608) 274-0853 | | Date: | October 28, 1996 | | Device/Trade Name: | Expanded Reference Values for DPX Series Bone Densitometer | | Common Name: | Bone Densitometer | | Classification Name: | Bone Densitometer 21CFR 892.1170 | | Predicate Device: | K89021 Modified DPX Bone Densitometer | ## 9.1 DESCRIPTION OF THE DEVICE: The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator’s Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials. 14 {1} 15 ## 9.3 CONCLUSION The expanded reference BMD values incorporated in this submission merely add to the reference value data already established and provided with the DPX series bone densitometers. These data can be used for comparative purposes by the clinician entirely at his/her discretion. No new safety and effectiveness questions are raised with the inclusion of these expanded reference values. ![img-0.jpeg](img-0.jpeg) Kenneth D. Buroker Printed Name Director, Regulatory Affairs Title --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K964307](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K964307) **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