← Product Code [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI) · K964263 # EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE (K964263) _Lunar Corp. · KGI · Nov 7, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K964263 ## Device Facts - **Applicant:** Lunar Corp. - **Product Code:** [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI.md) - **Decision Date:** Nov 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1170 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm²) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer. ## Device Story Accessory software for EXPERT-XL Bone Densitometer; estimates bone mineral density (BMD) in g/cm² for forearm and hand regions. Input: X-ray scan data from densitometer; 10-second scan duration. Processing: software analysis of scan data to calculate BMD. Output: BMD values displayed to clinician. Used in clinical settings by trained operators. Results assist clinicians in assessing bone health. Benefits: provides quantitative bone density measurements for diagnostic assessment. ## Clinical Evidence Bench testing and comparative analysis. Results correlate highly (r=0.96) with predicate DPX series measurements. In vivo short-term precision (CV) is 2% or less for all measured sites, comparable to DPX series densitometers. ## Technological Characteristics Software accessory for bone densitometry. Operates on EXPERT-XL Bone Densitometer hardware. Scan time: 10 seconds. Radiation exposure: 12 mrem. ## 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 - Forearm Software for Lunar DPX Series ([K915535](/device/K915535.md)) - Hand Software for Lunar DPX Series ([K953032](/device/K953032.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 NOV - 6 1996 K 96 4263 313 W. BELTLINE HIGHWAY MADISON, WI 53713 (608) 274-2663 ## 10.0 510(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 23, 1996 | | Device/Trade Name: | EXPERT-XL Forearm and Hand Acquisition and Analysis Software | | Common Name: | Bone Densitometer | | Classification Name: | Bone Densitometer 21CFR 892.1170 | | Predicate Device: | K915535 Forearm Software for Lunar DPX Series K953032 Hand Software for Lunar DPX Series | ## 10.1 DESCRIPTION OF THE DEVICE: The EXPERT-XL Hand and/or Forearm Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density BMD (in g/cm²) of the forearm and/or hand region provided for by the EXPERT-XL Bone Densitometer. ## 10.2 SUMMARY OF TECHNICAL CHARACTERISTICS Scans of the forearm or hand region take about 10 seconds. The EXPERT-XL Forearm and Hand software results correlate highly (r = 0.96) with the corresponding regions measured on the DPX series, which already has 510(k) clearance. Also, the average short term precision (CV) in vivo is 2% or under for all sites, which is comparable to that shown on DPX series densitometers. The radiation exposure of 12 mrem is higher than that for DPX series densitometers but remains low compared to the maximum permissible dose to the extremities. {1} 10.3 CONCLUSION The BMD results for the EXPERT-XL forearm/hand software option are comparable to the DPX results and have similar precision. No new safety and effectiveness questions are raised with the EXPERT-XL forearm and hand software accessory. Signed Kenneth D. Buroker Printed Name Director, Regulatory Affairs Title 22 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K964263](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K964263) **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