# K972882: Apollo

- Pathway: 510(k) (Traditional)
- Applicant: Norland Corp.
- Decided: Oct 31, 1997 after 87 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
Longest line of descent: 1 generation back to K891582 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891582: Modified Osteoanalyzer (# SPSHA110/220), Osteon, Inc. (1989) Summary page 1.
- K931996: Model Pdexa Bone Densitometer, Norland Corp. (1995) Summary page 1.

## Indications for use
The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.

Source page: https://510kreport.com/device/K972882
Methodology: https://510kreport.com/methodology