# K061595: Xaminer

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: Aug 17, 2006 after 70 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Xplorer 1000 Digital Radiographic x-ray detector: named in the summary without a submission number

## Most influential descendants
- K073056: Digital Radiography System, Model: QXR-9 (2007), 4 descendants of its own
- K080553: Digital Radiography System, Model QXR-16 (2008), 2 descendants of its own
- K101779: Clearvision DR 2000 Digital Radiography X-Ray System (2011), 0 descendants of its own
- K100703: Stationary X-Ray System (Detector) Model: Altas (2010), 0 descendants of its own
- K093816: Digital Radiography System, Models Galaxy 900 and 1600 (2010), 0 descendants of its own

## Indications for use
The Xaminer (510k submission device) is integrated into the user’s stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Xaminer (510k submission device) is not intended for mammography.

Source page: https://510kreport.com/device/K061595
Methodology: https://510kreport.com/methodology