Who is the manufacturer of EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE?

Lunar Corp. filed the 510(k) submission for EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE (K964263).

What is the FDA product code for EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE?

KGI. It is classified under 21 CFR 892.1170 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE?

Forearm Software for Lunar DPX Series (K915535); Hand Software for Lunar DPX Series (K953032).

Who can help prepare an FDA 510(k) submission like EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE

K964263 · Lunar Corp. · KGI · Nov 7, 1996 · Radiology

Device Facts

Record ID	K964263
Device Name	EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
Applicant	Lunar Corp.
Product Code	KGI · Radiology
Decision Date	Nov 7, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1170
Device Class	Class 2

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.

Indications for Use

Indicated for the estimation of bone mineral density (BMD) in the forearm and hand regions using the EXPERT-XL Bone Densitometer.

Regulatory Classification

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)
Hand Software for Lunar DPX Series (K953032)

Related Devices

K965226 — EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE · Lunar Corp. · Oct 3, 1997
K983271 — FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS · Lunar Corp. · Nov 18, 1998
K983269 — FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER · Lunar Corp. · Nov 18, 1998
K992677 — EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W · Hologic, Inc. · Sep 3, 1999
K133664 — ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS · Ge Medical Systems Ultrasound & Primary Care Diagn · May 15, 2014

Submission Summary (Full Text)

{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