# K071430: Synerad Omni, Models AN6255 and AN6265

- Pathway: 510(k) (Special)
- Applicant: Analogic Corp.
- Decided: Jun 21, 2007 after 29 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: 6 generations back to K900935 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043025: Synerad Omni, Digital X-Ray System, Model AN6250, Analogic Corp. (2004) Summary page 1.

## Indications for use
The AN6255 and AN6265 are digital X-ray general radiography systems intended for use by qualified/trained doctor or technician and are designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from these systems are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOMIPACS) network, clinical review station or to a film printer.

Source page: https://510kreport.com/device/K071430
Methodology: https://510kreport.com/methodology