510(k) · Cleared
ClearedCardiovascular Workstation, Model CWS 5000/CWS 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infimed, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 7, 1999 as substantially equivalent to K974086 (Eastman Kodak Company, 1998) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 7, 1999
- Review
- 66 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960043 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960043 Kodak Cardiology Digital Archive & Review SystemJamieson Film Co. · 1996
- This deviceK992575 Cardiovascular Workstation, Model CWS 5000/CWS 3000Infimed, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960043 | Kodak Cardiology Digital Archive & Review System | Jamieson Film Co. | 1996 | — |
| 0 (this device) | K992575 | Cardiovascular Workstation, Model CWS 5000/CWS 3000 | Infimed, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974086 | Kodak Digital Science Cardiac ViewerSummary page 1…em Classification Name: Picture Archival and Communications System ( as per 892.2050) Predicate substantially equivalent devices: Kodak Digital Science Cardiac Viewer ( K974086) Kodak Digital Science Cardiac Archive and Review System ( K960043) Device Description: The InfiMed Cardiovascular Workstation C… | 1998 |
| * | K960043 | Kodak Cardiology Digital Archive & Review SystemSummary page 1…( as per 892.2050) Predicate substantially equivalent devices: Kodak Digital Science Cardiac Viewer ( K974086) Kodak Digital Science Cardiac Archive and Review System ( K960043) Device Description: The InfiMed Cardiovascular Workstation CWS 5000 provides digital acquisition and review of DICOM images. Th… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 ancestors has a recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources (including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally (on hard drive, written to CD-R media and/or networks) or stored to permanent archive, using the DICOM standards. In…
Read the full statement (140 words)
The InfiMed Cardiovascular Workstation provides digital acquisition and review of cardiac images. The system can acquire images from a variety of sources (including through DICOM transfer, real-time high resolution 1024 line analog secondary image capture and high speed direct digital connection). Patient images may be stored locally (on hard drive, written to CD-R media and/or networks) or stored to permanent archive, using the DICOM standards. In addition, the Cardiovascular Workstation provides image review of patient studies in real-time or slow motion, as well as processing and analysis capability. Review functionality also includes multi-modality imaging to support diagnosis and therapy of cardiovascular patients. MR, CT, Nuclear, Ultrasound and CR imaging may be compared to cath lab cardiac and peripheral vascular angiography to enhance clinical analysis and save physician time. Images may be formatted for multi-modality display and printing on laser cameras.
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/K992575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992575: Cardiovascular Workstation, Model CWS 5000/CWS 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992575
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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