# K042232: NP-2600 Series Hardcopy Printers

- Pathway: 510(k) (Traditional)
- Applicant: Codonics, Inc.
- Decided: Oct 5, 2004 after 49 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: 3 generations back to K002146 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003481: Codonics NP-1660 Series Medical Printers, Model 1660, Codonics, Inc. (2001) Summary page 1.
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager, Codonics, Inc. (2002) Summary page 1.
- K030690: Codonics EP-1000 Medical Color Dry Imagers, Codonics, Inc. (2003) 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
- K092280: Cypher Dicom Print Solution (2009), 0 descendants of its own

## Indications for use
The intended uses of the NP-2600 Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; however, does not include digital mammography hardcopy. 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 essentially identical to the Codonics NP-1660 Series Medical Printers (Premarket notification K003481), the Codonics Horizon Series Medical Hardcopy Dry Imagers (Premarket notification K021054). The intended uses are identical to the Codonics EP-1000 Medical Image Hardcopy Color Printers (Premarket notification K030690) and the Seiko ColorPoint 1720 (Premarket notification K991282) in terms of color, reflective media output.

Source page: https://510kreport.com/device/K042232
Methodology: https://510kreport.com/methodology