# K953404: Osteo-Ray 100

- Pathway: 510(k) (Traditional)
- Applicant: Micro Focus Imaging, Inc.
- Decided: Nov 30, 1995 after 133 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071233: Xpert 40 Specimen Radiography System (2007), 18 descendants of its own
- K083510: Kubtec Xpert 20 (2009), 15 descendants of its own
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001 (2011), 14 descendants of its own
- K122428: Faxitron Specien Radiography System (2012), 4 descendants of its own
- K183624: Kubtec Mozart (Xpert42) (2019), 3 descendants of its own

Source page: https://510kreport.com/device/K953404
Methodology: https://510kreport.com/methodology