# K030962: DPX Series Bravo Duo Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Ge Lunar Corp.
- Decided: Jul 25, 2003 after 120 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904980 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982267: DPX-RX Bone Densitometer, Lunar Corp. (1998) Summary page 1.
- K904980: DPX-L and DPX-Alpha, Modification, Lunar (1990) Summary page 1.

## Recalls of this device
- Mar 16, 2018 · Class II · Z-1393-2018: Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct 

## 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.”

Source page: https://510kreport.com/device/K030962
Methodology: https://510kreport.com/methodology