510(k) · Cleared
Recalled · Class II · 2018DPX-RX Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · KGI Densitometer, Bone
Cleared on Aug 18, 1998 as substantially equivalent to K904980 (Lunar, 1990) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1990. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 18, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- KGI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904980 (1990). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK904980 DPX-L and DPX-Alpha, ModificationLunar · 1990
- This deviceK982267 DPX-RX Bone DensitometerLunar Corp. · 1998
- Descendant · cites it directly · 1 of its ownK052581 Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
- Descendant · cites it directly · 0 of its ownK180782 AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK072439 GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007
- Descendant · cites it directly · 0 of its ownK030962 DPX Series Bravo Duo Bone DensitometerGe Lunar Corp. · 2003 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K052581Lunar IdxaGe Medical Systems Ultrasound and Primary Care Dia · 2005 · cites it directly1descendant
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 2 generations on0descendants
- K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018 · cites it directly0descendants
- K072439GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile KitGe Medical Systems Ultrasound and Primary Care Dia · 2007 · cites it directly0descendants
- K030962DPX Series Bravo Duo Bone DensitometerGe Lunar Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904980 | DPX-L and DPX-Alpha, Modification | Lunar | 1990 | — |
| 0 (this device) | K982267 | DPX-RX Bone Densitometer | Lunar Corp. | 1998 | — |
| +1 | K052581 | Lunar Idxa | Ge Medical Systems Ultrasound and Primary Care Dia | 2005 | 1 |
| +2 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
| +1 | K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018 | — |
| +1 | K072439 | GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit | Ge Medical Systems Ultrasound and Primary Care Dia | 2007 | — |
| +1 | K030962 | DPX Series Bravo Duo Bone Densitometer | Ge Lunar Corp. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K904980 | DPX-L and DPX-Alpha, ModificationSummary page 1…one Densitometer Common Name: Bone Densitometer Classification Name: Bone Densitometer 21CFR 892.1170 Predicate Device: LUNAR DPX-Alpha and DPX-L 510(k) Accession Number K904980 LUNAR EXPERT 510(k) K945526 10.1 DESCRIPTION OF THE DEVICE: The DPX-RX Bone Densitometer provides an estimation of Bone Mineral… | 1990 |
| * | K945526 | Lunar ExpertSummary page 1…: Bone Densitometer Classification Name: Bone Densitometer 21CFR 892.1170 Predicate Device: LUNAR DPX-Alpha and DPX-L 510(k) Accession Number K904980 LUNAR EXPERT 510(k) K945526 10.1 DESCRIPTION OF THE DEVICE: The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm?) of t… | 1995 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1395-2018 | 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?
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-RX Bone Densitometer provides an estimate of BMD at the lumbar Spine and
proximal ferour regions. This BMD value can then be compared to a reference population at the
sole discretion of the physician.
The use of the DPX-RX Bone Densitometer is restricted to prescription use only. The
operator’s manual for the DPX-RX system contains 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982267: DPX-RX Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982267
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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