# K972822: Imation SE-204 Laser Imager

- Pathway: 510(k) (Traditional)
- Applicant: Imation Enterprises Corp.
- Decided: Nov 19, 1997 after 112 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K936152 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936152: 3M 1152 Laser Imager, 3M Information,Imaging and Electronic Sector (1994) Summary page 1.
- K964414: LR 5200 Laser Film Recorder, Bayer Corp., Agfa Div. (1997) Summary page 1.

## Indications for use
The Imation™ SE-204 laser imager is intended use as a high resolution hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-204 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to Digital Radiography and full view digital mammography for diagnostic use by medical radiologists and communications to referring physicians and their patients.

Source page: https://510kreport.com/device/K972822
Methodology: https://510kreport.com/methodology