510(k) · Cleared
ClearedCompacs, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Images Srl · LLZ System, Image Processing, Radiological
Cleared on Jun 22, 2004 as substantially equivalent to K012093 (Aetmed, S.P.A., 2001) and 3 other predicates after an 8-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Jun 22, 2004
- Review
- 8 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K941322 (1995). 30 ancestors in all, the oldest K896095 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK941322 Echo-ScanTomographic Tech · 1995
- 4 generations backK963807 Tomtec Echo-ScanTomtec Imaging Systems, Inc. · 1996
- 3 generations backK993394 Echo Scan, Easy ScanTomtec Imaging Systems GmbH · 1999
- 2 generations backK011582 Qcu Analytical Software PackageMedis Medical Imaging Systems BV · 2001
- 1 generation backK022940 IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 2002
- This deviceK041581 Compacs, Version 1.0Intelligent Images Srl · 2004
- Descendant · cites it directly · 0 of its ownK120514 CardiopacsLumedx · 2012
Most influential descendants
Showing 1 of 1 · See all- K120514CardiopacsLumedx · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941322 | Echo-Scan | Tomographic Tech | 1995 | — |
| −4 | K963807 | Tomtec Echo-Scan | Tomtec Imaging Systems, Inc. | 1996 | — |
| −3 | K993394 | Echo Scan, Easy Scan | Tomtec Imaging Systems GmbH | 1999 | — |
| −2 | K011582 | Qcu Analytical Software Package | Medis Medical Imaging Systems BV | 2001 | — |
| −1 | K022940 | IN-Vision View with Measurements Module, Model 1.0 | Intelligent Images Srl | 2002 | — |
| 0 (this device) | K041581 | Compacs, Version 1.0 | Intelligent Images Srl | 2004 | — |
| +1 | K120514 | Cardiopacs | Lumedx | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K012093 | Aetmed Image Processing SoftwareSummary page 2…P.A. VIA SIFFREDI 58 GENOVA, I- 16153, ITALY Tradename: AETMED IMAGE PROCESSING SOFTWARE 510(k) Number: K012093 Manufacturer: PROBLEM SOLVING CONCEPTS, INC. 8020 CASTLEWAY DR. INDIANAPO… | 2001 |
| * | K023112 | Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9Summary page 2…, INC. 8020 CASTLEWAY DR. INDIANAPOLIS, IN 46250, USA Tradename: PROSOLV® CARDIOVASCULAR 510(k) Number: K023112 Manufacturer: TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 UNTERSCHLEISS… | 2002 |
| * | K040546 | Image-Arena and Research-Arena ApplicationsSummary page 2…SYSTEMS, GMBH EDISONSTRASSE 6 UNTERSCHLEISSHEIM, D-85716, GERMANY Tradename: IMAGE-ARENA 510(k) Number: K040546 Manufacturer: INTELLIGENT IMAGES SRL VIALE CEMBRANO 4C/4 GENOVA, 1-16148,… | 2004 |
| * | K022940 | IN-Vision View with Measurements Module, Model 1.0Summary page 2…VIALE CEMBRANO 4C/4 GENOVA, 1-16148, ITALY Tradename: IN-VISION VIEW WITH MEASUREMENTS MODULE 510(k) Number: K022940 Additional substantial equivalence information is provided in the following substantial equivalence section. Intelligent Ima… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120514 | Cardiopacs | 2012 | 0 |
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 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K120514 (Lumedx, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012093.
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?
ComiPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, printing, processing, analyzing, reporting and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies.
The software can be used in a variet' of network configurations ranging from a stand-alone workstation to a network of workstations connected to a ComPACS server configuration. DICOM compatible imaging devices can transfer studies directly to the ComPACS archive using DICOM network protocols or DICOM removable media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041581: Compacs, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041581
Report an extraction error
Are you the manufacturer?
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