# K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager

- Pathway: 510(k) (Traditional)
- Applicant: Codonics, Inc.
- Decided: May 9, 2002 after 38 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 K002146 (2000). 4 ancestors in all.
6 later devices descend from it; 4 cite 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 3.
- K012941: Drystar, Model 4500M, Agfa Corp. (2001) Summary page 3.

## Most influential descendants
- K060440: Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film Imager (2006), 1 descendant of its own
- K042232: NP-2600 Series Hardcopy Printers (2004), 1 descendant of its own
- K024188: UP-DF500 Filmstation Digital Film Imager (2003), 1 descendant of its own
- K111566: Dryview Chroma Imaging System (2011), 0 descendants of its own
- K092280: Cypher Dicom Print Solution (2009), 0 descendants of its own

## Indications for use
The intended uses of the Horizon® 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. 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-1660 Series Medical Printers (Premarket notification K003481) as a combined color, film, reflective media imager. The intended uses are identical to the FUJI FM-DP 2636 Dry Imager (Premarket notification K962967) and AGFA DryStar Model 4500M ((Premarket notification K012941) in terms of dry radiological output devices with the addition of 14 x 17 media formats.

Source page: https://510kreport.com/device/K021054
Methodology: https://510kreport.com/methodology