510(k) · Cleared
ClearedInfinitt Cardiology Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitt Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 6, 2008 as substantially equivalent to K034059 (Sectra AB, 2004) and 2 other predicates after a 51-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Nov 6, 2008
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K896095 (1990). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK993761 Cardiovascular Measurement System - ViewMedis Medical Imaging Systems BV · 1999
- 2 generations backK034059 Sectra Angiography Package and Sectra Cardiology PackageSectra AB · 2004
- 1 generation backK042781 Ipacs CardioRealtimeimage, Inc. · 2004
- This deviceK082706 Infinitt Cardiology PacsInfinitt Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K993761 | Cardiovascular Measurement System - View | Medis Medical Imaging Systems BV | 1999 | — |
| −2 | K034059 | Sectra Angiography Package and Sectra Cardiology Package | Sectra AB | 2004 | — |
| −1 | K042781 | Ipacs Cardio | Realtimeimage, Inc. | 2004 | — |
| 0 (this device) | K082706 | Infinitt Cardiology Pacs | Infinitt Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 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? (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 |
|---|---|---|---|
| * | K034059 | Sectra Angiography Package and Sectra Cardiology PackageSummary page 1…logical Product code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K034059 K042781 K051649 Device system, image system, image… | 2004 |
| * | K042781 | Ipacs CardioSummary page 1…code: LLZ Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K034059 K042781 K051649 Device system, image system, image system, image… | 2004 |
| * | K051649 | Vericis Cardiovascular Image and Information System, Model 4.0Summary page 1…Device Classification: 892.2050 Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K034059 K042781 K051649 Device system, image system, image system, image Classification… | 2005 |
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?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K034059.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
INFINITT Cardiology PACS TM is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082706: Infinitt Cardiology Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082706
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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