# K011949: Elk Laser Imager, Model EL-Dry 4000

- Pathway: 510(k) (Traditional)
- Applicant: Nishimoto Sangyo Co., Ltd.
- Decided: Aug 29, 2001 after 69 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.
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. The FDA summary names its predicate without a number.
- (no number) Kodak DryView 8100: named in the summary without a submission number

## Indications for use
The EL-DRY 4000 digitizes image data output from medical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.

Source page: https://510kreport.com/device/K011949
Methodology: https://510kreport.com/methodology