# K941362: Bone Mineral Densitometer

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Aug 30, 1995 after 527 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023398: Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery (2002), 19 descendants of its own
- K061561: Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone Densitometers (2006), 13 descendants of its own
- K072664: GE Lunar Femur Strength Software (2008), 7 descendants of its own
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K060111: Iva (Mxa II Software Option) (2006), 6 descendants of its own

Source page: https://510kreport.com/device/K941362
Methodology: https://510kreport.com/methodology