# K063188: Del-Ims

- Pathway: 510(k) (Traditional)
- Applicant: Del Medical Imaging Corp.
- Decided: Nov 30, 2006 after 41 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: 3 generations back to K900935 (1990). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980970: Iirad Directray Operator Console, Sterling Diagnostic Imaging, Inc. (1998) Summary page 1.

## Most influential descendants
- K093480: Cuattro Unomd (2010), 1 descendant of its own
- K161937: CuattroDR (2016), 0 descendants of its own

## Indications for use
The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K063188
Methodology: https://510kreport.com/methodology