510(k) · Cleared
ClearedSectra Angiography Package and Sectra Cardiology Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sectra AB · LLZ System, Image Processing, Radiological
Cleared on Mar 9, 2004 as substantially equivalent to K993761 (Medis Medical Imaging Systems BV, 1999) and 3 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K896095 (1990). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 3 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 2 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 1 generation backK993761 Cardiovascular Measurement System - ViewMedis Medical Imaging Systems BV · 1999
- This deviceK034059 Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004
- Descendant · cites it directly · 1 of its ownK042781 Ipacs CardioRealtimeimage, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK082706 Infinitt Cardiology PacsInfinitt Co., Ltd. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −3 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −2 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −1 | K993761 | Cardiovascular Measurement System - View | Medis Medical Imaging Systems BV | 1999 | — |
| 0 (this device) | K034059 | Sectra Angiography Package and Sectra Cardiology Package | Sectra AB | 2004 | — |
| +1 | K042781 | Ipacs Cardio | Realtimeimage, Inc. | 2004 | — |
| +1 | K082706 | Infinitt Cardiology Pacs | Infinitt Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 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? (4)
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 |
|---|---|---|---|
| * | K993761 | Cardiovascular Measurement System - ViewSummary page 1…Name: Image Processing System (LLZ) (21 CFR § 892.2050) Predicate Devices: Applicant: Medical Imaging Systems (MEDIS) 5 10(k) Number: K993761 Device: QCA-View (Cardiovascular Measurement System - View) Applicant: Medical Imagin… | 1999 |
| * | K993763 | Quantitative Analysis of Coronary Angiograms (Qca)Summary page 1…Device: QCA-View (Cardiovascular Measurement System - View) Applicant: Medical Imaging Systems 5 10(k) Number: K993763 Device: QCA-CMS (Quantitative Analysis of Coronary Angiograms) Applicant: Medical Ima… | 1999 |
| * | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV)Summary page 1…vice: QCA-CMS (Quantitative Analysis of Coronary Angiograms) Applicant: Medical Imaging Systems (MEDIS) 5 10(k) Number: K993765 Device: QLV-CMS (Quantitative Analysis of Left Ventricular Angiograms) Applicant: Me… | 1999 |
| * | K023970 | Quantitative Vascular Angiography - CMSSummary page 1…QLV-CMS (Quantitative Analysis of Left Ventricular Angiograms) Applicant: Medical Imaging Systems (MEDIS) 510(k) Number: K023970 Device: QVA-CMS (QVA-CMS Analytical software package) Device Description: Sectra Angiography and… | 2003 |
What descends from it? (2)
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 14 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K042781 (Realtimeimage, Inc., 2004) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K993761.
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 Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs. This information is suitable for use in the following applications: 1. Scientific…
Read the full statement (105 words)
The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs.
This information is suitable for use in the following applications:
1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics,
2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
Typical users of the device are trained professionals, e.g. physicians, radiologists, cardiologists and scientists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K034059: Sectra Angiography Package and Sectra Cardiology Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K034059
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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