# K030690: Codonics EP-1000 Medical Color Dry Imagers

- Pathway: 510(k) (Traditional)
- Applicant: Codonics, Inc.
- Decided: Apr 30, 2003 after 56 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 K971760 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962364: Codonics Medical Printer (NP-1600M,NP1600MD), Codonics, Inc. (1996) Summary page 1.
- K991282: Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series, Seiko Instruments USA, Inc. (1999) Summary page 1.

## Most influential descendants
- K042232: NP-2600 Series Hardcopy Printers (2004), 1 descendant of its own
- K092280: Cypher Dicom Print Solution (2009), 0 descendants of its own
- K042159: Kodak Color Medical Imager 1000 (2004), 0 descendants of its own

## Indications for use
The intended uses of the EP-1000 Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of diredindirect medical imaging modality outputs. The hardcopy output includes however is not limited to, nuclear medicine, ultrasound, CT (especially 3-0 reconstruction), MRI, and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. The intended uses are identical to the Codonics NP-1600 Series Medical Printers (Premarket notification K962364) as a color, reflective media imager. The intended uses are identical to the Seiko ColorPoint 1720 (Premarket notification K991282) in terms of color, reflective media output.

Source page: https://510kreport.com/device/K030690
Methodology: https://510kreport.com/methodology