# K111098: Innovaxion FP, Innovaxion FP 1600 Plus, Magellan

- Pathway: 510(k) (Special)
- Applicant: Imaging Dynamics Company, Ltd.
- Decided: May 27, 2011 after 37 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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
Longest line of descent: 7 generations back to K981556 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071402: X3C 1600 Plus Digital Radiographic System, Imaging Dynamics Company, Ltd. (2007) Summary page 1.
- K102123: Vizion DR, Viztek, Inc. (2011) Summary page 1.
- K090742: Digital Flat Panel X-Ray Detector, Model LTX240AA01-a, Samsung Mobile Display Co., Ltd. (2009) Summary page 1.

## Indications for use
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking 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. Not intended for mammography.

Source page: https://510kreport.com/device/K111098
Methodology: https://510kreport.com/methodology