510(k) Report

510(k) · Cleared

Cleared

FXA (TM)

K110765510(k) TraditionalCleared Nov 4, 2011231-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

Aces GmbH · LLZ System, Image Processing, Radiological

Cleared on Nov 4, 2011 as substantially equivalent to K022585 (Medical Metrics, Inc., 2002) after a 231-day review. Its family tree reaches back 1 generation to 2002.

Decided
Nov 4, 2011
Review
231 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K022585 (2002). No later device cites it as a predicate yet.

K022585 · Kimax Qma · Medical Metrics, Inc. · 20022000200220042006200820102012
K022585 · Kimax Qma · Medical Metrics, Inc. · 20020
  1. Root · 1 generation backK022585 Kimax QmaMedical Metrics, Inc. · 2002
  2. This deviceK110765 FXA (TM)Aces GmbH · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022585Kimax QmaMedical Metrics, Inc.2002—
0 (this device)K110765FXA (TM)Aces GmbH2011—
FIG. 1 — Lineage of K110765, 2002–2011Source: 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
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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
*K022585Kimax Qma
Summary page 2
…AS7S ZS-? Predicate Device(s): The selected predicate device is the QMATM software by Medical Metrics Inc. (K022585). Summary of Characteristic Performance Data: The predicate device and the FXATM software have been tested and characterized in…
Medical Metrics, Inc.2002—

Also cleared against K022585: 3 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?

  • Its one ancestor has no recall.
  • 3 other devices also cite its predicate K022585.

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. 2011, 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 FXATM software is a quantitative imaging software application. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. The FXATM software permits users to review static and dynamic digital images acquired from a variety of radiographic sources for the purpose of facilitating a quantitative assessment of relative motion and static measurement parameters. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a report containing graphics, charts, text and statistical data.

Indications for use as stated in the FDA summary.

Also cleared against K022585

3 other devices cite the same predicate.

  • K221632Spine CAMP™Medical Metrics, Inc. · 2022
  • K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2013
  • K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection DeviceOrtho Kinematics, Inc. · 2011

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/K110765 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110765: FXA (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110765

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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