# K984252: Imation Trimatic Digital System

- Pathway: 510(k) (Traditional)
- Applicant: Imation Corp.
- Decided: Jan 25, 1999 after 59 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933129 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982785: Film Digitizer Model 2905, Array Corp. (1998) Summary page 1.

## Indications for use
The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.

Source page: https://510kreport.com/device/K984252
Methodology: https://510kreport.com/methodology