# K012093: Aetmed Image Processing Software

- Pathway: 510(k) (Traditional)
- Applicant: Aetmed, S.P.A.
- Decided: Sep 21, 2001 after 78 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 K896095 (1990). 6 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000474: View NT, Electromed Intl., Ltd. (2000) Summary page 1.
- K982862: Radworks Medical Imaging Software with Quality Control Module, Applicare Medical Imaging, B.V. (1998) Summary page 1.
- K955092: Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire, Cemax-Icon, Inc. (1996) Summary page 1.
- (no number) AutoRad Regustr: named in the summary without a submission number

## Most influential descendants
- K013694: Nidek Advanced Vision Information System (Navis) (2002), 61 descendants of its own
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for (2008), 50 descendants of its own
- K090439: FORUM (2009), 32 descendants of its own
- K093313: Synergy (2009), 29 descendants of its own
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match (2012), 25 descendants of its own

## Indications for use
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.

Source page: https://510kreport.com/device/K012093
Methodology: https://510kreport.com/methodology