# K011617: Lifejet Printer 400

- Pathway: 510(k) (Traditional)
- Applicant: Ferrania S.P.A. Stabilimento DI Ferrania
- Decided: Jun 8, 2001 after 14 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: 2 generations back to K951948 (1995). 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)
- K983905: Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600, Eastman Kodak Company (1999) Summary page 1.

## Indications for use
The LifeJet™ Printer 400 is an ink jet printer designed to provide referral high quality color and/or gray scale hard copies of medical images generated by medical equipment. The LifeJet™ Printer 400 has been developed to be used together with LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to achieve the best quality medical images.

Source page: https://510kreport.com/device/K011617
Methodology: https://510kreport.com/methodology