# K964274: Writestar, and Viewstar

- Pathway: 510(k) (Traditional)
- Applicant: Comview Corp.
- Decided: Jan 10, 1997 after 77 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942264 (1994). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942264: DDR with Dpa and 30/60 Options (Digital Viewstation), Eigen Video (1994) Summary page 1.
- K941979: Video Plus with Analytical Workstation, Camtronics, Ltd. (1994) Summary page 1.
- K955184: Acculupe, E For M Imaging Systems Div., Marquette Electronic (1996) Summary page 1.

## Most influential descendants
- K974679: The TCS-Medcon's Telecardiology System (1998), 4 descendants of its own
- K112720: Mckesson Horizon Cardiology (2012), 3 descendants of its own
- K151850: McKesson Cardiology (2015), 2 descendants of its own
- K181080: McKesson Cardiology (2018), 1 descendant of its own
- K212528: Change Healthcare Cardiology (2021), 0 descendants of its own

## Indications for use
The WriteStar is designed to create convenient and efficient storage, display, and analysis of digital images of heart catheterization and other coronary procedures involving cine-film applications. The WriteStar is designed to support the cine-less cath lab environment and is meant to replace 35mm cine film, and cine projectors currently being used by the majority of cardiac catheterization laboratories. Cine film is currently being used as the permanent archival media for images acquired during heart catheterization. The WriteStar is able to function as an independent unit that accepts images from any imaging system an RS-170 video source. The ViewStar is a review station. The ViewStar does not have the WriteStar’s capability to record to a CD-R disk. The ViewStar can only read (view) a case study from a DICOM compliant CD-R disk. The ViewStar/Write Star is able to review patient images from A CD-R disk that was previously recorded from an imaging device that uses the DICOM standard. The patient images are transferred from the CD-R disk to the internal hard disk of the WriteStar. Once the images are on the hard disk, the Cardiologist, or other qualified personnel, has the same means to review and analyze images. Analysis is provided via 3" party industry standard software. The WriteStar interfaces with commercially available devices that digitize and/or process cine images and or fluoro images and records these images on a 2GB or 4GB SCSI hard drives. These images are simultaneously displayed on the system console for image quality verficication. Images are acquired from the source device via RS-170 interface. The images are then displayed for review and analysis similar to a cine film projector. As in the cine film projector, the WriteStar will display cine images of a particular patient without the use of film.

Source page: https://510kreport.com/device/K964274
Methodology: https://510kreport.com/methodology