510(k) Report

510(k) · Cleared

Cleared

Kimax Qma

K022585510(k) TraditionalCleared Oct 11, 200267-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

Medical Metrics, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 11, 2002 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.

Decided
Oct 11, 2002
Review
67 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

15 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2013: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2023: 4 descendants cleared2017: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK022585 Kimax QmaMedical Metrics, Inc. · 2002
  2. Descendant · cites it directly · 10 of its ownK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
  3. Descendant · cites it directly · 9 of its ownK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
  4. Descendant · 2 generations on · 8 of its ownK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
  5. Descendant · 3 generations on · 7 of its ownK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
  6. Descendant · 4 generations on · 6 of its ownK192109 KOALAIb Lab GmbH · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2011: 22013: 12014: 12017: 12019: 12021: 12022: 12023: 42025: 22026: 1
2011high 4 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all
  • K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection…Ortho Kinematics, Inc. · 2011 · cites it directly10descendants
  • K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc. · 2013 · cites it directly9descendants
  • K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc. · 2014 · 2 generations on8descendants
  • K172327VMA™ System version 3.0Ortho Kinematics, Inc. · 2017 · 3 generations on7descendants
  • K192109KOALAIb Lab GmbH · 2019 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022585Kimax QmaMedical Metrics, Inc.2002—
+1K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data…Ortho Kinematics, Inc.2011—
+1K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc.2013—
+2K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc.20144
+3K172327VMA™ System version 3.0Ortho Kinematics, Inc.2017—
+4K192109KOALAIb Lab GmbH2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201310
201410
201710
201910
202110
202210
202340
202520
202610
FIG. 1 — Lineage of K022585, 2002–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (15)

See all 15

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection…Ortho Kinematics, Inc.201110
K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc.20139
K221632Spine CAMP™Medical Metrics, Inc.20222
K110765FXA (TM)Aces GmbH20110

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?

  • Of its descendants, K112109 (Ortho Kinematics, Inc., 2011) has gone furthest, with 10 descendants of its own.

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.

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?

KIMAX QMATM 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. KIMAX QMATM permits users to review static and dynamic digital images acquired from a variety of radiographic sources. It also facilitates quantitative assessment of motion in radiographic images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a “motion analysis” report containing graphics, charts and text.

Indications for use as stated in the FDA 510(k) statement.

More from Medical Metrics, Inc.

5 FDA decisions under this applicant name. See the company

  • K231668Spine CAMP™ (1.1)Medical Metrics, Inc. · 2023
  • K221632Spine CAMP™Medical Metrics, Inc. · 2022
  • K013098Kimax Remote Viewing StationMedical Metrics, Inc. · 2001
  • K010187Kimax, Model 1024Medical Metrics, Inc. · 2001

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/K022585 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022585: Kimax Qma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022585

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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