# K973090: Medstation

- Pathway: 510(k) (Traditional)
- Applicant: Program S.R.L.
- Decided: Oct 28, 1997 after 71 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
IviedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomegraphy (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.

Source page: https://510kreport.com/device/K973090
Methodology: https://510kreport.com/methodology