# K972163: Imation SE-196 Laser Imager

- Pathway: 510(k) (Traditional)
- Applicant: Imation Corp.
- Decided: Sep 5, 1997 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M (Imation™) 8700 Laser Imager: named in the summary without a submission number

## Most influential descendants
- K042158: Kodak Medical Imager 300 (2004), 0 descendants of its own

## Indications for use
The Imation™ SE-196 laser imager is intended use as a high quality 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-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.

Source page: https://510kreport.com/device/K972163
Methodology: https://510kreport.com/methodology