510(k) · Cleared
ClearedCardiovascular Measurement System - View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological
Cleared on Dec 28, 1999 as substantially equivalent to K982862 (Applicare Medical Imaging, B.V., 1998) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1990. 6 later devices descend from it.
- Decided
- Dec 28, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896095 (1990). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 2 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 1 generation backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- This deviceK993761 Cardiovascular Measurement System - ViewMedis Medical Imaging Systems BV · 1999
- Descendant · cites it directly · 2 of its ownK112807 X-Ray VvaMedis Medical Imaging Systems BV · 2012
- Descendant · cites it directly · 2 of its ownK034059 Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004
- Descendant · 2 generations on · 1 of its ownK222036 MPXA-2000Medipixel, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK042781 Ipacs CardioRealtimeimage, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK252634 Imagine® Enterprise SuiteSoftlink International Private Limited · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112807X-Ray VvaMedis Medical Imaging Systems BV · 2012 · cites it directly2descendants
- K034059Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004 · cites it directly2descendants
- K222036MPXA-2000Medipixel, Inc. · 2023 · 2 generations on1descendant
- K042781Ipacs CardioRealtimeimage, Inc. · 2004 · 2 generations on1descendant
- K252634Imagine® Enterprise SuiteSoftlink International Private Limited · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −2 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −1 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| 0 (this device) | K993761 | Cardiovascular Measurement System - View | Medis Medical Imaging Systems BV | 1999 | — |
| +1 | K112807 | X-Ray Vva | Medis Medical Imaging Systems BV | 2012 | — |
| +1 | K034059 | Sectra Angiography Package and Sectra Cardiology Package | Sectra AB | 2004 | — |
| +2 | K222036 | MPXA-2000 | Medipixel, Inc. | 2023 | — |
| +2 | K042781 | Ipacs Cardio | Realtimeimage, Inc. | 2004 | — |
| +3 | K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K982862 | Radworks Medical Imaging Software with Quality Control ModuleSummary page 1…Class. Name - System, Image Processing; Regulation Number : 21 CFR 892.2050 (90 LLZ; Class II) 3) Predicate Device(s) : RadWorks Medical Imaging Software 510(k) Number: K982862 and K962699 Description of the device: CMS-View is a professional state-of-the-art DICOM Review Station, designed for use with… | 1998 |
| * | K962699 | Radworks Medical Imaging SoftwareSummary page 1…- System, Image Processing; Regulation Number : 21 CFR 892.2050 (90 LLZ; Class II) 3) Predicate Device(s) : RadWorks Medical Imaging Software 510(k) Number: K982862 and K962699 Description of the device: CMS-View is a professional state-of-the-art DICOM Review Station, designed for use with Microsoft Wi… | 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112807 (Medis Medical Imaging Systems BV, 2012) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K982862.
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?
CMS-View provides a means for the playback and/or review of medical images or imaging sequences by physicians, scientists or other medical personnel. These medical images may origiftace from different imaging modalities (x-ray, MR, ultrasound, nuclear, etc.) and are input to the CMS-VIEW system via industry standard formats (DICOM) or by creating a digital equivalent of a video-format (via frame-grabber). Standard image review tools are provided…
Read the full statement (120 words)
CMS-View provides a means for the playback and/or review of medical images or imaging sequences by physicians, scientists or other medical personnel. These medical images may origiftace from different imaging modalities (x-ray, MR, ultrasound, nuclear, etc.) and are input to the CMS-VIEW system via industry standard formats (DICOM) or by creating a digital equivalent of a video-format (via frame-grabber). Standard image review tools are provided, including zoom, brightness and contrast controls.
The review of medical images is suitable for use by physicians and scientists in the following applications:
1. Scientific and research studies, selecting and asséssing medical images that are of interest,
2. Review and analysis of patient medical images, providing physicians and administrators with convenient access and review features/capabilities.
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/K993761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993761: Cardiovascular Measurement System - View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993761
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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