510(k) · Cleared
Recalled · Class II · 2018DPX Series Bravo Duo Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Lunar Corp. · KGI Densitometer, Bone
Cleared on Jul 25, 2003 as substantially equivalent to K982267 (Lunar Corp., 1998) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Jul 25, 2003
- Review
- 120 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904980 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904980 | DPX-L and DPX-Alpha, Modification | Lunar | 1990 | — |
| −1 | K982267 | DPX-RX Bone Densitometer | Lunar Corp. | 1998 | 1 |
| 0 (this device) | K030962 | DPX Series Bravo Duo Bone Densitometer | Ge Lunar Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982267 | DPX-RX Bone DensitometerSummary page 1…Bone Densitometer 21CFR 892.1170 Predicate Device: LUNAR PRODIGY 5 1O(k) K982267 LUNAR DPX-Alpha and DPX-L 5 1O(k) K904980 11.1… | 1998 |
| * | K904980 | DPX-L and DPX-Alpha, ModificationSummary page 1…DIGY 5 1O(k) K982267 LUNAR DPX-Alpha and DPX-L 5 1O(k) K904980 11.1 DESCRIPTION OF THE DEVICE: The DPX series Bravo, Duo Bone Densitometerprovides an estimation of Bone Mineral… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2018 | Class II | Z-1393-2018 | Software design | 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 patient information will be listed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K982267.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030962: DPX Series Bravo Duo Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030962
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026