510(k) · Cleared
ClearedDicompacs, Model 5.2, Dicompacs DX-R, Model 1.4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oehm Und Rehbein GmbH · LLZ System, Image Processing, Radiological
Cleared on Dec 11, 2009 as substantially equivalent to K070618 (Oehm Und Rehbein GmbH, 2007) after a 217-day review. Its family tree reaches back 6 generations to 1990. 58 later devices descend from it.
- Decided
- Dec 11, 2009
- Review
- 217 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896095 (1990). 8 ancestors in all. 58 later devices descend from it, 5 citing it directly.
- 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 backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 2 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 1 generation backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- This deviceK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- Descendant · cites it directly · 16 of its ownK110033 Feel-DRCSImfou Co., Ltd. · 2011
- Descendant · cites it directly · 16 of its ownK101517 Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · Recalled
- Descendant · 2 generations on · 14 of its ownK161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model…Sedecal., Sa. · 2016 · Recalled
- Descendant · cites it directly · 14 of its ownK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- Descendant · 2 generations on · 13 of its ownK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K110033Feel-DRCSImfou Co., Ltd. · 2011 · cites it directly16descendants
- K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · cites it directly16descendants
- K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. · 2016 · 2 generations on14descendants
- K100449Minxray Model CMDR-2SMinxray, Inc. · 2010 · cites it directly14descendants
- K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014 · 2 generations on13descendants
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 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −2 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −1 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| 0 (this device) | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| +1 | K110033 | Feel-DRCS | Imfou Co., Ltd. | 2011 | — |
| +1 | K101517 | Sedecal Mobile Digital Diagnostic X-Ray | Sedecal., Sa. | 2011 | 4 |
| +2 | K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal., Sa. | 2016 | 13 |
| +1 | K100449 | Minxray Model CMDR-2S | Minxray, Inc. | 2010 | — |
| +2 | K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray | Minxray, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070618 | Dicompacs, Model 5Summary page 1…Regulation Number: 21 CFR 892.2050 Common Product Name: Radiological Image Processing System 510(k) Number: K070618 Executive Summary Page 1 of 3 dicomPA… | 2007 |
What descends from it? (58)
See all 585 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 19 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K110033 (Imfou Co., Ltd., 2011) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K070618.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
dicomPACS and dicomPACS DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS and dicomPACS DX-R also provides services for administering the data.…
Read the full statement (180 words)
dicomPACS and dicomPACS DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS and dicomPACS DX-R also provides services for administering the data.
dicomPACS DX-R can control X-ray generators. dicomPACS DX-R is not approved for the acquisition of mammographic image data.
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 MR resolution and meets other technical specifications reviewed and accepted by FDA.
Functions to be carried out using dicomPACS and dicomPACS DX-R are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.
dicomPACS and dicomPACS DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091364: Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091364
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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