510(k) · Cleared
ClearedIB Clinic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Biometrics, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 11, 2013 as substantially equivalent to K080762 (Imaging Biometrics, LLC, 2008) and 1 other predicate after an 80-day review. Its family tree reaches back 11 generations to 1991. 1 later device descends from it.
- Decided
- Jan 11, 2013
- Review
- 80 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K911667 (1991). 48 ancestors in all, the oldest K896095 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 7 generations between
- 3 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 2 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 1 generation backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- This deviceK123302 IB ClinicImaging Biometrics, LLC · 2013
- Descendant · cites it directly · 0 of its ownK211356 GIQuantMotilent, Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 10 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 9 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 8 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 7 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 6 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 5 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 4 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 3 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 2 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 1 generation backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- This deviceK123302 IB ClinicImaging Biometrics, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K211356GIQuantMotilent, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −10 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −9 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −8 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −7 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −6 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −5 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −4 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −3 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −2 | K073167 | Brainstat Software Option for GE Signa MR Scanner | Ge Medical Systems, LLC | 2008 | — |
| −1 | K080762 | IB Neuro, Version 1.0 | Imaging Biometrics, LLC | 2008 | — |
| 0 (this device) | K123302 | IB Clinic | Imaging Biometrics, LLC | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 21.5 · 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? (2)
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 |
|---|---|---|---|
| * | K080762 | IB Neuro, Version 1.0Summary page 2…lly equivalent to the following legally marketed devices that are currently cleared by the FDA: 510(k) Trade Name IManufacturer K080762 lB Neuro vi1.0 Imaging Biometrics K090546 nordiclCE Nordic Imaging Lab 5. Dev… | 2008 |
| * | K090546 | Modification to Nordicice SoftwareSummary page 2…currently cleared by the FDA: 510(k) Trade Name IManufacturer K080762 lB Neuro vi1.0 Imaging Biometrics K090546 nordiclCE Nordic Imaging Lab 5. Device Description: Clinic is a platform independent image pr… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211356 | GIQuant | 2021 | 0 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 48 ancestors have a recall of any class.
- Of its descendants, K211356 (Motilent, Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K080762.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
IS Clinic v1 -0 (Clinic) is a post-processing software toolkit designed to be integrated into existing medical image visualization applications running on standard computer hardware. Clinic accepts relevant DICOM image sets, such as dynamic perfusion and diffusion image sets. Clinic generates various perfusion- and diffusion-related parameters, standardized image sets, and image intensity differences. The results are saved to a DICOM image file and may…
Read the full statement (259 words)
IS Clinic v1 -0 (Clinic) is a post-processing software toolkit designed to be integrated into existing medical image visualization applications running on standard computer hardware. Clinic accepts relevant DICOM image sets, such as dynamic perfusion and diffusion image sets. Clinic generates various perfusion- and diffusion-related parameters, standardized image sets, and image intensity differences. The results are saved to a DICOM image file and may be further visualized an an imaging workstation-
Clinic is designed to aid trained physicians in advanced image assessment, treatment consideration, and monitoring of therapeutic response. The information provided by Clinic should not be used in isolation when making patient management decisions.
Dynamic Perfusion Analysis - Generates parametric perfusion maps used for visualization of temporal variations in dynamic datasets, showing changes in image intensity over time- These maps may aid in the assessment of the extent and type of perfusion, blood volume and vascular permeability changes-
Dynamic Diffusion Analysis - Generates apparent diffusion coefficient maps used for the visualization of apparent water movement in soft tissue throughout the body on both voxel-by-voxel and sub-voxel bases. These images may aid in the assessment of the extent of diffusion in tisue-
Image Comparison - Generates co-registered image sets- Generates standardized image sets calibrated to an arbitrary scale to facilitate comparisons between independent image sets- Generates voxel-by-voxel maps of the image intensity differences between image sets acquired at different times- Facilitates selection and DICOM export of user-selected regions of interest (ROls)-These processes may enable easier identification of image intensity differences between images and easier selection and processing of ROls-
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123302: IB Clinic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123302
Report an extraction error
Are you the manufacturer?
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