(120 days)
No
The summary describes a standard bone densitometer that estimates BMD based on physical measurements and comparison to a reference population. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device estimates Bone Mineral Density for diagnostic purposes and does not provide therapy.
Yes
The device is a bone densitometer that provides an estimate of Bone Mineral Density (BMD), which is used by a physician to compare to a reference population. This process of estimating a medical parameter (BMD) to aid in diagnosis or assessment of a medical condition aligns with the definition of a diagnostic device.
No
The device description explicitly mentions "mechanical features" and a "scan arm," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The DPX Series Bravo, Duo Bone Densitometer measures bone mineral density (BMD) directly on the patient's body (in vivo) using a physical method (likely X-ray or similar). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it provides an estimate of BMD at specific anatomical sites on the patient.
- Device Description: The description reinforces that it provides an estimation of BMD of the spine, femur, and forearm.
The device is a medical device used for diagnostic purposes, but it is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DPX Series Bravo, Duo Bone Densitometer provides an estimate of BMD at the spine, proximal femur and forearm regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only. The operator's manual for the DPX Series Bravo, Duo system contain the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
Product codes
90 KGI
Device Description
The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine, femur, forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
The DPX series Bravo. Duo Bone Densitometer performs a 90 second scan, with a total skin exposure dose of 2.0 mrem per measurement. The radiation exposure of 2.0 mrem is comparable to the predicate Prodigy and DPX-L bone densitometers.
The BMD spine estimations in vivo provided by the DPX series Bravo, Duo correlate r>0.983 with the Prodigy. The average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo. The average short-term precision (%CV) in vitro was
§ 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 General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are in a bold, sans-serif font and are surrounded by a circular border with decorative swirls.
JUL 2 5 2003
GE Medical Systems : (7:14:10)
der and des Mems 1507
11.0 510(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: | James P. Raskob
GE LUNAR Corporation
726 Heartland Trail
Madison, WI 53717 |
|----------------------|-------------------------------------------------------------------------------------|
| Phone: | (608) 826-7425 |
| Fax: | (608) 826-7825 |
| Date: | March 25, 2003 |
| Device/Trade Name: | DPX Series Bravo, Duo Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | LUNAR PRODIGY
510(k) K982267
LUNAR DPX-Alpha and DPX-L
510(k) K904980 |
DESCRIPTION OF THE DEVICE: 11.1
The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
1
SUMMARY OF TECHNICAL CHARACTERISTICS 11.2
The DPX series Bravo. Duo Bone Densitometer performs a 90 second scan, with a total skin exposure dose of 2.0 mrem per measurement. The radiation exposure of 2.0 mrem is comparable to the predicate Prodigy and DPX-L bone densitometers.
The BMD spine estimations in vivo provided by the DPX series Bravo, Duo correlate r>0.983 with the Prodigy. The average BMD values obtained in 45 subjects in vivo were very similar with Prodigy and DPX series Bravo, Duo. The average short-term precision (%CV) in vitro was