510(k) · Cleared
ClearedHipax Medical Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steinhart Medizinsysteme GmbH · LLZ System, Image Processing, Radiological
Cleared on Sep 21, 2005 as substantially equivalent to K962699 (Applicare Medical Imaging, B.V., 1996) and 1 other predicate after a 23-day review. Its family tree reaches back 4 generations to 1990. 80 later devices descend from it.
- Decided
- Sep 21, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896095 (1990). 5 ancestors in all. 80 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 backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- This deviceK052411 Hipax Medical Imaging SoftwareSteinhart Medizinsysteme GmbH · 2005
- Descendant · cites it directly · 78 of its ownK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- Descendant · 2 generations on · 58 of its ownK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- Descendant · 3 generations on · 16 of its ownK110033 Feel-DRCSImfou Co., Ltd. · 2011
- Descendant · 3 generations on · 16 of its ownK101517 Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK110040 OmnivisionModern Module, Inc. · 2011
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K070618Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007 · cites it directly78descendants
- K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009 · 2 generations on58descendants
- K110033Feel-DRCSImfou Co., Ltd. · 2011 · 3 generations on16descendants
- K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · 3 generations on16descendants
- K110040OmnivisionModern Module, Inc. · 2011 · 2 generations on15descendants
View 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 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| 0 (this device) | K052411 | Hipax Medical Imaging Software | Steinhart Medizinsysteme GmbH | 2005 | — |
| +1 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| +2 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| +3 | K110033 | Feel-DRCS | Imfou Co., Ltd. | 2011 | — |
| +3 | K101517 | Sedecal Mobile Digital Diagnostic X-Ray | Sedecal., Sa. | 2011 | 4 |
| +2 | K110040 | Omnivision | Modern Module, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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.
What descends from it? (80)
See all 802 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 15 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K070618 (Oehm Und Rehbein GmbH, 2007) has gone furthest, with 78 descendants of its own.
- 8 other devices also cite its predicate K962699.
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 Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, DR, CT, MRI, US, RF units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed…
Read the full statement (194 words)
The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, DR, CT, MRI, US, RF units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD.
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.
Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.
Users of the Hipax Medical Imaging Software are typically trained medical professionals, for example, radiologists, orthopedists, clinicians, technologists, and others.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052411: Hipax Medical Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052411
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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