510(k) · Cleared
ClearedArix Rad Acquisition Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · LLZ System, Image Processing, Radiological
Cleared on Feb 20, 2013 as substantially equivalent to K110033 (Imfou Co., Ltd., 2011) after an 85-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 20, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 2 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 1 generation backK110033 Feel-DRCSImfou Co., Ltd. · 2011
- This deviceK123650 Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2013
- Descendant · cites it directly · 0 of its ownK182537 RADMAX Digital Imaging SoftwareDRGEM Corporation · 2019
- Descendant · cites it directly · 0 of its ownK170729 Examion X-AQSExamion GmbH · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | 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 | — |
| −1 | K110033 | Feel-DRCS | Imfou Co., Ltd. | 2011 | — |
| 0 (this device) | K123650 | Arix Rad Acquisition Console | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2013 | — |
| +1 | K182537 | RADMAX Digital Imaging Software | DRGEM Corporation | 2019 | — |
| +1 | K170729 | Examion X-AQS | Examion GmbH | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K110033 | Feel-DRCSSummary page 1…e: LLZ . Predicate Device: 21 CFR 807. 92(a)(3) . ARiX RAD Acquisition Console™ is substantially equivalent to: |system, image processing, radiological 510(K) Number K110033 l [Device Name |FEEL-DRCS | Applicant IMFOU CO., LTD #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, Korea [Regulati… | 2011 |
What descends from it? (2)
2 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 23 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K182537 (DRGEM Corporation, 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K110033.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The ARiX RAD Acquisition Console™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other…
Read the full statement (392 words)
The ARiX RAD Acquisition Console™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. The ARiX RAD Acquisition Console™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems.
The ARiX RAD Acquisition Console™ system is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only and users must be qualified to create and diagnose radiological image data.
The main functions of the ARiX RAD Acquisition Console™ system are as follows:
a) Acquisition and storage of digital X-ray images from a digital X-ray Detector.
b) Input Study information (patient information, exam information).
c) Management of stored (archived) images.
d) Image processing for enhancement of archived images.
e) Review of stored images.
f) Editing of images.
g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.)
h) For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) or a need to interface with installed X-ray system, the:
• Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions.
• Communication between Generator Console and ARiX RAD Acquisition Console™ system.
The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the ARiX RAD Acquisition Console™ system since the ARiX RAD Acquisition Console™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The ARiX RAD Acquisition Console™ system can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company.
The ARiX RAD Acquisition Console™ system does not control exposure and electrical change and calibration X-ray. If the X-ray generator does not allow interfacing with external software (e.g. ARiX RAD Acquisition Console™ system), the ARiX RAD Acquisition Console™ system software cannot be interfaced with X-ray Generator.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123650: Arix Rad Acquisition Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123650
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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