510(k) Report

510(k) · Cleared

Cleared

BIT-Motion

K211039510(k) TraditionalCleared Dec 15, 2021252-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

Dde Mri Solutions, Ltd. · LLZ System, Image Processing, Radiological

Cleared on Dec 15, 2021 as substantially equivalent to K043216 (Confirma, Inc., 2005) after a 252-day review. Its family tree reaches back 5 generations to 1991.

Decided
Dec 15, 2021
Review
252 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K913770 (1991). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1994: 1 other ancestorK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK033400 · Seno Advantage · Ge Medical Systems W-400 · 2003 · recalledK043216 · Cadstream Version 4.0 · Confirma, Inc. · 20051990199520002005201020152020
Other ancestors, by generation 2 generations back: 2 other ancestors5 generations back: 1 other ancestor K043216 · Cadstream Version 4.0 · Confirma, Inc. · 2005K033400 · Seno Advantage · Ge Medical Systems W-400 · 2003 · recalledK020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991−50
  1. Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
  5. 1 generation backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
  6. This deviceK211039 BIT-MotionDde Mri Solutions, Ltd. · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−4K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−3K020483Advantage Workstation 4.1GE Medical Systems20022
−2K033400Seno AdvantageGe Medical Systems W-40020036
−1K043216Cadstream Version 4.0Confirma, Inc.2005—
0 (this device)K211039BIT-MotionDde Mri Solutions, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200310
200410
FIG. 1 — Lineage of K211039, 1991–2021Source: 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
*K043216Cadstream Version 4.0
Summary page 4
…Radiology Device Class: II Type of 510(k) Submission: Traditional Identification of the Legally Marketed Predicate Device CADstream Version 4.0 (K043216) Manufactured by Confirma, INC Device Description The BIT-Motion is a software package that is aimed to process MRI images. The…
Confirma, Inc.2005—

Also cleared against K043216: 8 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?

  • The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K043216.

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. 2021, 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 BIT-Motion is a stand-alone image post processing software. The Bit-Motion is intended for use as a PACS device, which is interfaced to the clinics' LAN. It receives clinical studies from hospital modalities, processes functional volumetric data and generates parametric maps that display changes in image intensity. It also includes manual display manipulation, annotation and control tools, which assist professional users to evaluate the displayed…

Read the full statement (170 words)

The BIT-Motion is a stand-alone image post processing software. The Bit-Motion is intended for use as a PACS device, which is interfaced to the clinics' LAN. It receives clinical studies from hospital modalities, processes functional volumetric data and generates parametric maps that display changes in image intensity. It also includes manual display manipulation, annotation and control tools, which assist professional users to evaluate the displayed maps and to transfer the results to the PACS, in DICOM format.

The BIT-Motion indications for use are receiving breast studies from MRI scanners and processing them to generate DTI (Diffusion Tensor Imaging) 2D and 3D parametric maps that display changes in the values of water diffusion coefficients and directions, as well as in indices defining diffusion anisotropy. The device-displayed DTI parametric maps are evaluated by the users. The device is indicated for use by trained radiologists and may provide information on breast water diffusion features. The BIT-Motion should not be used in isolation for evaluating breast tissue features or for making patient management decisions.

Indications for use as stated in the FDA summary.

Also cleared against K043216

8 other devices cite the same predicate.

  • K090038Syngo BrevisSiemens Medical Solutions USA, Inc. · 2009
  • K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 20091 recall
  • K081556Cadstream, Version 5.0Confirma, Inc. · 2009
  • K080196Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
  • K070244AEGISSentinelle Medical, Inc. · 2007
  • K052023Cadimas Version 1.0Alan Penn & Associates., Inc. · 2005

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/K211039 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211039: BIT-Motion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211039

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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