# K040995: Synerad Multi Digital X-Ray System, Model AN6150

- Pathway: 510(k) (Abbreviated)
- Applicant: Analogic Corp.
- Decided: May 25, 2004 after 39 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900935 (1990). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033345: AN5150 and AN7150 Digital Radiology Systems, Analogic Corp. (2003) Summary page 1.

## Most influential descendants
- K043025: Synerad Omni, Digital X-Ray System, Model AN6250 (2004), 1 descendant of its own
- K071430: Synerad Omni, Models AN6255 and AN6265 (2007), 0 descendants of its own

## Recalls of this device
- Oct 14, 2005 · Not classified · Z-0196-06: Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possiible injury of the user or patient.

## Indications for use
The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is 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 the AN6150 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 (DICOM/PACS) network, clinical review station or to a film printer.

Source page: https://510kreport.com/device/K040995
Methodology: https://510kreport.com/methodology