# K982267: DPX-RX Bone Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Lunar Corp.
- Decided: Aug 18, 1998 after 50 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: 1 generation back to K904980 (1990). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904980: DPX-L and DPX-Alpha, Modification, Lunar (1990) Summary page 1.
- K945526: Lunar Expert, Lunar Corp. (1995) Summary page 1.

## Most influential descendants
- K052581: Lunar Idxa (2005), 1 descendant of its own
- K252718: Lunar Astra (2026), 0 descendants of its own
- K180782: Aria (2018), 0 descendants of its own
- K072439: GE Lunar DPX & Prodigy Series Dexa Bone Densitometers with Mobile Kit (2007), 0 descendants of its own
- K030962: DPX Series Bravo Duo Bone Densitometer (2003), 0 descendants of its own

## Recalls of this device
- Mar 16, 2018 · Class II · Z-1395-2018: 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-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.”

Source page: https://510kreport.com/device/K982267
Methodology: https://510kreport.com/methodology