# K060440: Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film Imager

- Pathway: 510(k) (Special)
- Applicant: Codonics, Inc.
- Decided: Mar 16, 2006 after 23 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). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager, Codonics, Inc. (2002) Summary page 2.

## Most influential descendants
- K092280: Cypher Dicom Print Solution (2009), 0 descendants of its own

## Indications for use
The intended uses of the Horizon XL are identical to the Codonics Horizon® Series Medical Hardcopy Dry Imagers (premarket notification K021054); high resolution hard copy imaging of digital image source material combining color, film, reflective media in one imager. 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 addition of 14" x 36" and 14" x 51" true size "long" film and (TBD) reflective Direct Vista Paper media permits digital direct orthopaedic application hardcopy including diagnosis and analysis of scoliosis, weight bearing spine/hip/knee, and long bone/hip Prosthetic and orthopedic appliances work-up and surgical planning. Horizon XL is applicable to true-size hardcopy of whole body CT, MRI and Angiographic and Venous flow imaging procedures.

Source page: https://510kreport.com/device/K060440
Methodology: https://510kreport.com/methodology