510(k) Report

510(k) · Cleared

Cleared

Examion X-AQS

K170729510(k) TraditionalCleared Jul 18, 2017131-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

Examion GmbH · LLZ System, Image Processing, Radiological

Cleared on Jul 18, 2017 as substantially equivalent to K123650 (Compania Mexicana DE Radiologia Cgr, S.A. DE C.V., 2013) after a 131-day review. Its family tree reaches back 9 generations to 1990.

Decided
Jul 18, 2017
Review
131 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K896095 (1990). 11 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 5 generations between
  3. 3 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
  4. 2 generations backK110033 Feel-DRCSImfou Co., Ltd. · 2011
  5. 1 generation backK123650 Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2013
  6. This deviceK170729 Examion X-AQSExamion GmbH · 2017
Show all 9 generations
  1. Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
  2. 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
  3. 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
  4. 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
  5. 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
  6. 4 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
  7. 3 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
  8. 2 generations backK110033 Feel-DRCSImfou Co., Ltd. · 2011
  9. 1 generation backK123650 Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. · 2013
  10. This deviceK170729 Examion X-AQSExamion GmbH · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K896095Images-on-Call Teleradiology SystemDevices & Services Co.1990—
−8K962699Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V.1996—
−7K982862Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V.1998—
−6K012211Efilm WorkstationEfilm Medical, Inc.20011
−5K020995Efilm Workstation with ModulesEfilm Medical, Inc.20022
−4K070618Dicompacs, Model 5Oehm Und Rehbein GmbH2007—
−3K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH2009—
−2K110033Feel-DRCSImfou Co., Ltd.2011—
−1K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.2013—
0 (this device)K170729Examion X-AQSExamion GmbH2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200510
FIG. 1 — Lineage of K170729, 1990–2017Source: 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 21.5 · 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
*K123650Arix Rad Acquisition Console
Summary page 4
…LLZ Predicate Device: 21 CFR 807. 92(a)(3) Device Classification Name system, image processing, radiological 510(k) Number K123650 Device Name ARIX RAD ACQUISITION CONSOLE Applicant COMPANIA MEXICANA…
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.2013—

Also cleared against K123650: 1 other device →

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 27 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • 1 other device also cites its predicate K123650.

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. 2017, this device’s year, is highlighted.

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?

The Examion X-AQS™ 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…

Read the full statement (386 words)

The Examion X-AQS™ 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 Examion X-AQS™ 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.x by using DICOM and network systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians. Contraindications: Examion X-AQS™ is not intended for creation of fluoroscopic/radioscopic, or angiographic images. The main functions of the Examion X-AQS™ system are:

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, ¢) 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 Examion X-AQS™, The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the Examion X-AQS™ system since the Examion X-AQS™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The Examion X-AQS™ 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 Examion X-AQS™ system does not control exposure and electrical charge and calibration X-ray. If the X-ray generator does not allow interfacing with external software the Examion X-AQS™ 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.

Cite this page

510(k) Report. “K170729: Examion X-AQS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170729

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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