# K092280: Cypher Dicom Print Solution

- Pathway: 510(k) (Traditional)
- Applicant: Virtual Imaging, Inc.
- Decided: Oct 16, 2009 after 80 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: 4 generations back to K002146 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060440: Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film Imager, Codonics, Inc. (2006) Summary page 1.
- K042232: NP-2600 Series Hardcopy Printers, Codonics, Inc. (2004) Summary page 1.

## Indications for use
This device is intended for high resolution hard copy imaging of digital image source material (DICOM). 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. Not for mammography use.

Source page: https://510kreport.com/device/K092280
Methodology: https://510kreport.com/methodology