510(k) · Cleared
ClearedWritestar, and Viewstar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comview Corp. · LMB Device, Digital Image Storage, Radiological
Cleared on Jan 10, 1997 as substantially equivalent to K942264 (Eigen Video, 1994) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- Jan 10, 1997
- Review
- 77 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K942264 (1994). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942264 DDR with Dpa and 30/60 Options (Digital Viewstation)Eigen Video · 1994
- This deviceK964274 Writestar, and ViewstarComview Corp. · 1997
- Descendant · cites it directly · 4 of its ownK974679 The TCS-Medcon's Telecardiology SystemMedcon, Ltd. · 1998
- Descendant · 2 generations on · 3 of its ownK112720 Mckesson Horizon CardiologyMckesson Israel, Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK151850 McKesson CardiologyMckesson Israel, Ltd. · 2015
- Descendant · 4 generations on · 1 of its ownK181080 McKesson CardiologyChange Healthcare Israel, Ltd. · 2018
- Descendant · 5 generations on · 0 of its ownK212528 Change Healthcare CardiologyChange Healthcare Israel, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K974679The TCS-Medcon's Telecardiology SystemMedcon, Ltd. · 1998 · cites it directly4descendants
- K112720Mckesson Horizon CardiologyMckesson Israel, Ltd. · 2012 · 2 generations on3descendants
- K151850McKesson CardiologyMckesson Israel, Ltd. · 2015 · 3 generations on2descendants
- K181080McKesson CardiologyChange Healthcare Israel, Ltd. · 2018 · 4 generations on1descendant
- K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd. · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942264 | DDR with Dpa and 30/60 Options (Digital Viewstation) | Eigen Video | 1994 | — |
| 0 (this device) | K964274 | Writestar, and Viewstar | Comview Corp. | 1997 | — |
| +1 | K974679 | The TCS-Medcon's Telecardiology System | Medcon, Ltd. | 1998 | — |
| +2 | K112720 | Mckesson Horizon Cardiology | Mckesson Israel, Ltd. | 2012 | — |
| +3 | K151850 | McKesson Cardiology | Mckesson Israel, Ltd. | 2015 | — |
| +4 | K181080 | McKesson Cardiology | Change Healthcare Israel, Ltd. | 2018 | — |
| +5 | K212528 | Change Healthcare Cardiology | Change Healthcare Israel, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942264 | DDR with Dpa and 30/60 Options (Digital Viewstation)Summary page 1…ed predicate devices with the same intended use include the a) Digital Disk Recorder (DDR) or the Digital ViewStation with Dual Path Archiver manufactured by Eigen (RE: K942264); b) the Video Plus System with Analytical Workstation manufactured by Camtronics (RE: K941979); and c) the AccuLupe digital imag… | 1994 |
| * | K941979 | Video Plus with Analytical WorkstationSummary page 1…the Digital ViewStation with Dual Path Archiver manufactured by Eigen (RE: K942264); b) the Video Plus System with Analytical Workstation manufactured by Camtronics (RE: K941979); and c) the AccuLupe digital image archival and review station (RE: K955184). Description: The WriteStar is an independent com… | 1994 |
| * | K955184 | AcculupeSummary page 1…42264); b) the Video Plus System with Analytical Workstation manufactured by Camtronics (RE: K941979); and c) the AccuLupe digital image archival and review station (RE: K955184). Description: The WriteStar is an independent computerized system used in the cardiac catherization laboratories for managing,… | 1996 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K974679 (Medcon, Ltd., 1998) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (294 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964274: Writestar, and Viewstar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026