# K063392: Imco-Stat

- Pathway: 510(k) (Traditional)
- Applicant: Imco Technologies
- Decided: Dec 12, 2006 after 33 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: 5 generations back to K945188 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051809: Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System, Medical Insight A/S (2005)
- K012844: Marosis Pacs, Marotech, Inc. (2001) Summary page 1.

## Most influential descendants
- K112480: View 1 Imaging (2011), 0 descendants of its own

## Indications for use
IMCO-STAT is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT server in DICOM 3.0 Part 10 and JPEG format. IMCO-STAT is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments, This is accomplished using an executable client application on a receiving entity with the appropriate hardware. 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/K063392
Methodology: https://510kreport.com/methodology