# K033345: AN5150 and AN7150 Digital Radiology Systems

- Pathway: 510(k) (Special)
- Applicant: Analogic Corp.
- Decided: Nov 19, 2003 after 30 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: 3 generations back to K900935 (1990). 7 ancestors in all.
3 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)
- K001341: DR5000 Dedicated Chest X-Ray System, Analogic Corp. (2000)
- K001336: DR9000 Digital Radiography X-Ray System, Analogic Corp. (2000)
- K980970: Iirad Directray Operator Console, Sterling Diagnostic Imaging, Inc. (1998) Summary page 1.

## Most influential descendants
- K040995: Synerad Multi Digital X-Ray System, Model AN6150 (2004), 2 descendants of its own
- 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

## Indications for use
The AN5150 is a digital X-ray chest system intended for use by qualified trained doctor or technician and is designed to perform radiographic chest examinations. The AN7150 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 AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator’s workstation seconds after the x-ray exposure. After acceptance 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/K033345
Methodology: https://510kreport.com/methodology