# K060210: Mediport

- Pathway: 510(k) (Traditional)
- Applicant: Maxant Technologies, Inc.
- Decided: Feb 10, 2006 after 14 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: 6 generations back to K913475 (1991). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051521: Regius RS-1000, Medical Image Processing Workstation, Konica Minolta Medical & Graphic, Inc. (2005) Summary page 2.
- K052461: Syngo Imaging Version V20A, Siemens AG Medical Solutions (2005) Summary page 2.
- K042867: Philips Orthopaedic Applications, Philips Medical Systems North America, Inc. (2004) Summary page 3.
- K050485: 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB), Totoku Electric Co., Ltd. (2005) Summary page 3.
- K050619: 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB, Totoku Electric Co., Ltd. (2005) Summary page 3.
- K052276: Nio 2MP-20 and E-2620 S, Barcoview (2005) Summary page 3.

## Indications for use
The MEDIPORT is a medical grade device to be used as a platform for PACS software or DICOM viewer software. It is intended for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories. In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required. This device in not qualified or intended for use for mammographic purposes.

Source page: https://510kreport.com/device/K060210
Methodology: https://510kreport.com/methodology