# K092307: Imasight 4600 Digital Radiography Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Imasight, Inc.
- Decided: Aug 25, 2009 after 26 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
Longest line of descent: 1 generation back to K063247 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063247: Xplorer 1800 Digital Radiographic System with Universal Stand, Imaging Dynamics Company, Ltd. (2006) Summary page 1.

## Most influential descendants
- K181565: Aquarius 8600 Digital Radiography Sensor (2018), 0 descendants of its own

## Indications for use
The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.

Source page: https://510kreport.com/device/K092307
Methodology: https://510kreport.com/methodology