# K980970: Iirad Directray Operator Console

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Diagnostic Imaging, Inc.
- Decided: Jun 8, 1998 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900935 (1990). 4 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973206: Sterling Diagnostic Imaging Direct Radiography, Sterling Diagnostic Imaging, Inc. (1997) Summary page 1.
- K964250: Linx Networking System, Sterling Diagnostic Imaging, Inc. (1996) Summary page 1.
- K944149: Micro X-80 HF, Fischer Imaging Corp. (1994) Summary page 1.

## Most influential descendants
- K033345: AN5150 and AN7150 Digital Radiology Systems (2003), 3 descendants of its own
- K063188: Del-Ims (2006), 2 descendants of its own
- K040995: Synerad Multi Digital X-Ray System, Model AN6150 (2004), 2 descendants of its own
- K093480: Cuattro Unomd (2010), 1 descendant of its own
- K043025: Synerad Omni, Digital X-Ray System, Model AN6250 (2004), 1 descendant of its own

## Indications for use
The DirectRay™ Operator Console has application whenever the transmission of radiographic images and associated patient text data is desired to take place from an input device, such as any radiographic equipment which uses the DirectRay™ device, to any output device, such as hardcopy, softcopy, or archive devices.

Source page: https://510kreport.com/device/K980970
Methodology: https://510kreport.com/methodology