# K042700: Image Medical Acquisition Station (Imas)

- Pathway: 510(k) (Traditional)
- Applicant: Erad Imagemedical Corp.
- Decided: Nov 8, 2004 after 39 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 K896095 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002911: XSCAN32 Teleradiology Software, Radiographic Digital Imaging, Inc. (2001) Summary page 2.
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 2.

## Indications for use
Image Medical Acquisition Station (IMAS) is a PACS and teleradiology software application used to acquire digitized film images, add and modify patient and study demographics, and transmit the results to DICOM PACS systems, archives and workstations. IMAS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. Image Medical Acquisition Station (IMAS) is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography 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/K042700
Methodology: https://510kreport.com/methodology