510(k) · Cleared
ClearedGIQuant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motilent, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 8, 2021 as substantially equivalent to K123302 (Imaging Biometrics, LLC, 2013) after a 189-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Nov 8, 2021
- Review
- 189 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K911667 (1991). 49 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 12 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 8 generations between
- 3 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 2 generations backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- 1 generation backK123302 IB ClinicImaging Biometrics, LLC · 2013
- This deviceK211356 GIQuantMotilent, Ltd. · 2021
Show all 12 generations
- Root · 12 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 11 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 10 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 9 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 8 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 7 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 6 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 5 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 4 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 3 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 2 generations backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- 1 generation backK123302 IB ClinicImaging Biometrics, LLC · 2013
- This deviceK211356 GIQuantMotilent, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −11 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −10 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −9 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −8 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −7 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −6 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −5 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −4 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −3 | K073167 | Brainstat Software Option for GE Signa MR Scanner | Ge Medical Systems, LLC | 2008 | — |
| −2 | K080762 | IB Neuro, Version 1.0 | Imaging Biometrics, LLC | 2008 | — |
| −1 | K123302 | IB Clinic | Imaging Biometrics, LLC | 2013 | — |
| 0 (this device) | K211356 | GIQuant | Motilent, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 21.6 · 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 |
|---|---|---|---|
| * | K123302 | IB ClinicSummary page 4…ing legally marketed devices that are currently cleared by the FDA: 510(k) reference Device Name Manufacturer Clearance date K123302 IB Clinic v1.0 (clinic) Imaging Biometrics, LLC 11 January 2013 4. Device Descriptio… | 2013 |
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 7 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 49 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ 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
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?
GIQuant is a post-processing software integrated into existing medical imaging workflows that is intended to derive motion related parameters from abdominal data obtained during magnetic resonance imaging (MRI).
GIQuant is designed to aid trained physicians in advanced image assessment, treatment consideration, and monitoring of therapeutic response. The information provided by GIQuant should not be used in isolation when making patient management decisions.
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/K211356 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211356: GIQuant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211356
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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