510(k) Report

510(k) · Cleared

Cleared

Imorgon Ultrasound Pacs Solutions

K050736510(k) TraditionalCleared May 5, 200545-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sea Ridge Software, Inc. · LLZ System, Image Processing, Radiological

Cleared on May 5, 2005 as substantially equivalent to K023772 (Acuson Corp., 2002) after a 45-day review. Its family tree reaches back 4 generations to 1995.

Decided
May 5, 2005
Review
45 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K950279 (1995). 7 ancestors in all, the oldest K925965 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1993: 1 other ancestorK950279 · TOMTECP90 · Tomtec Imaging Systems, Inc. · 1995K964803 · Univision Echocardiology System · Network Concepts, Inc. · 1997K980060 · Echolink · Mpacs, LLC · 1998K023772 · Kinetdx Picture Archiving and Communications System · Acuson Corp. · 2002 · recalled1990199520002005
Other ancestors, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor K023772 · Kinetdx Picture Archiving and Communications System · Acuson Corp. · 2002 · recalledK980060 · Echolink · Mpacs, LLC · 1998K964803 · Univision Echocardiology System · Network Concepts, Inc. · 1997K950279 · TOMTECP90 · Tomtec Imaging Systems, Inc. · 19950
  1. Root · 4 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
  2. 3 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
  3. 2 generations backK980060 EcholinkMpacs, LLC · 1998
  4. 1 generation backK023772 Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · Recalled
  5. This deviceK050736 Imorgon Ultrasound Pacs SolutionsSea Ridge Software, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K950279TOMTECP90Tomtec Imaging Systems, Inc.1995—
−3K964803Univision Echocardiology SystemNetwork Concepts, Inc.1997—
−2K980060EcholinkMpacs, LLC1998—
−1K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp.20025
0 (this device)K050736Imorgon Ultrasound Pacs SolutionsSea Ridge Software, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199620
FIG. 1 — Lineage of K050736, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.6 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K023772Kinetdx Picture Archiving and Communications System
Summary page 1
…orgon Ultrasound PACS Solutions software is substantially equivalent to the Siemens (Acuson Corn.) KinetDx Picture Archiving & Communications System (K023772). Paget1 of3 1.6 Device Desc…
Acuson Corp.20025

Also cleared against K023772: 2 other devices →

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 10 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K023772.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

imorgon Ultrasound PACS Solutions is a medical image and information management system that is intended to transmit, store, retrieve, print and process DICOM digital medical images and associated medical information from various ultrasound imaging systems. It may also be used for general radiogical viewing from other modalities such as MRI, CT or nuclear medicine. imorgon Ultrasound PACS Solutions is indicated for use by trained medical professionals…

Read the full statement (141 words)

imorgon Ultrasound PACS Solutions is a medical image and information management system that is intended to transmit, store, retrieve, print and process DICOM digital medical images and associated medical information from various ultrasound imaging systems. It may also be used for general radiogical viewing from other modalities such as MRI, CT or nuclear medicine.

imorgon Ultrasound PACS Solutions is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians and medical technologists. imorgon is also indicated for soft copy diagnostic interpretation of medical images and video by physicians trained in such practice.

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.

Also cleared against K023772

2 other devices cite the same predicate.

  • K062229CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc. · 2006
  • K041029KinetdxSiemens Medi Cal Solutions, Inc. · 20041 recall

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K050736 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050736: Imorgon Ultrasound Pacs Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050736

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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