(44 days)
K 93 4040
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No
The description explicitly states the software does not interpret data, diagnose, or make recommendations, and there is no mention of AI/ML terms or performance studies typically associated with such technologies.
No
The device is a software accessory that generates reports from densitometer data and physician comments. It does not provide any diagnostic, treatment, or interpretive functions that would qualify it as therapeutic. Its purpose is solely for communication of results.
No
The device is a report generator that assists in communicating existing densitometer results; it does not interpret, diagnose, or make treatment recommendations.
Yes
The device is described as a "software accessory" that processes data from a separate hardware device (bone mineral densitometers) and generates reports. It explicitly states it is software and does not modify the original data, indicating it is a software-only component.
Based on the provided information, the LUNAR Report Generator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The LUNAR Report Generator processes data from a bone mineral densitometer, which is a device that measures bone density directly in the patient, not from a specimen taken from the patient.
- The primary function is communication, not diagnosis or interpretation of biological samples. The software assists in communicating existing densitometer results and physician comments. It explicitly states it does not interpret, advise, diagnose, assign risk, or make treatment recommendations.
- The data is not modified. The software takes data from the densitometer and formats it for reporting, but it doesn't perform any analysis or modification of the raw data that would be typical of an IVD.
The device description clearly positions it as a software accessory for reporting purposes, not for analyzing biological samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Report Generator assists the physician in communicating densitometer results to the patient and the patient's referring physician.
Product codes
Not Found
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 93 4040
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.1170 Bone densitometer.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "LUNAR" in bold, black letters. The font is sans-serif and the letters are closely spaced together. The word appears to be a logo or title, and the overall impression is strong and impactful. The background is plain white.
K96194
(608) 274-2663 MADISON, WI 53713 313 W. BELTLINE HIGHWAY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
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 |
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.
1
CONCLUSION 9.2
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.
Tory Ayring
Signed
Gary Syring Printed Name
Director, Regulatory Affairs Title
16 May '96
Date