# K173241: Med-Tab

- Pathway: 510(k) (Traditional)
- Applicant: Plum Medical Solutions GmbH
- Decided: Mar 23, 2018 after 168 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 K942120 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062488: IQ-System Pacs System, Image Information Systems, Ltd. (2006) Summary page 4.

## Indications for use
MED-TAB, is a computer hardware/software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Source page: https://510kreport.com/device/K173241
Methodology: https://510kreport.com/methodology