510(k) · Cleared
ClearedImco-Stat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imco Technologies · LLZ System, Image Processing, Radiological
Cleared on Dec 12, 2006 as substantially equivalent to K051809 (Medical Insight A/S, 2005) and 1 other predicate after a 33-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Dec 12, 2006
- Review
- 33 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945188 (1995). 14 ancestors in all, the oldest K920319 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 4 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 3 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 2 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 1 generation backK051809 Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data…Medical Insight A/S · 2005
- This deviceK063392 Imco-StatImco Technologies · 2006
- Descendant · cites it directly · 0 of its ownK112480 View 1 ImagingKarl Storz Endoscopy America, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K112480View 1 ImagingKarl Storz Endoscopy America, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −4 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −3 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −2 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −1 | K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data… | Medical Insight A/S | 2005 | — |
| 0 (this device) | K063392 | Imco-Stat | Imco Technologies | 2006 | — |
| +1 | K112480 | View 1 Imaging | Karl Storz Endoscopy America, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System | 2005 |
| * | K012844 | Marosis PacsSummary page 1…and technical characternstics as the Medical Insight EasyViz system (KO51809) and Marotech, Inc . Marosis PACS System (K012844), IM(lC I,.'2h ; ct It iK S:';unix';,… | 2001 |
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 |
|---|---|---|---|
| K112480 | View 1 Imaging | 2011 | 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 11 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K112480 (Karl Storz Endoscopy America, Inc., 2011) has gone furthest, with 0 descendants of its own.
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?
IMCO-STAT is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT server in DICOM 3.0 Part 10 and JPEG format. IMCO-STAT is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments, This is accomplished using an executable client…
Read the full statement (124 words)
IMCO-STAT is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT server in DICOM 3.0 Part 10 and JPEG format.
IMCO-STAT is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments, This is accomplished using an executable client application on a receiving entity with the appropriate hardware.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063392: Imco-Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063392
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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