510(k) · Cleared
ClearedOlea Sphere V3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olea Medical · LLZ System, Image Processing, Radiological
Cleared on Mar 3, 2016 as substantially equivalent to K132095 (Olea Medical, 2013) and 3 other predicates after a 174-day review. Its family tree reaches back 11 generations to 1997. 3 of the 65 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- Mar 3, 2016
- Review
- 174 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K971684 (1997). 47 ancestors in all, the oldest K896095 (1990). 17 later devices descend from it, 11 citing it directly. 3 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations between
- 3 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 1 generation backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- This deviceK152602 Olea Sphere V3.0Olea Medical · 2016
- Descendant · cites it directly · 1 of its ownK223532 Olea S.I.A. Neurovascular V1.0Olea Medical · 2023
- Descendant · cites it directly · 1 of its ownK211059 CereFlow™ V1.2Translational Mri, LLC · 2023
- Descendant · cites it directly · 1 of its ownK212565 CoverScan v1Perspectum, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK203582 QUIBIM Precision Prostate (qp-Prostate)Quibim S.L. · 2021
- Descendant · cites it directly · 1 of its ownK182716 Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. · 2019
Show all 11 generations
- Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 9 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 7 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 6 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 5 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 4 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 3 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 1 generation backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- This deviceK152602 Olea Sphere V3.0Olea Medical · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K223532Olea S.I.A. Neurovascular V1.0Olea Medical · 2023 · cites it directly1descendant
- K211059CereFlow™ V1.2Translational Mri, LLC · 2023 · cites it directly1descendant
- K212565CoverScan v1Perspectum, Ltd. · 2022 · cites it directly1descendant
- K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L. · 2021 · cites it directly1descendant
- K182716Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −10 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −9 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −8 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −7 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −6 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −5 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −4 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −3 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −2 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −1 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| 0 (this device) | K152602 | Olea Sphere V3.0 | Olea Medical | 2016 | — |
| +1 | K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | 2023 | — |
| +1 | K211059 | CereFlow™ V1.2 | Translational Mri, LLC | 2023 | — |
| +1 | K212565 | CoverScan v1 | Perspectum, Ltd. | 2022 | — |
| +1 | K203582 | QUIBIM Precision Prostate (qp-Prostate) | Quibim S.L. | 2021 | — |
| +1 | K182716 | Brain Perfusion (BP) application | Philips Medical Systems Nederland B.V. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
3 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K132095 | Olea SphereSummary page 6…cate device with regard to indications for use, performance and technological characteristics: 1) 510(k) Number: K132095 Trade Name: Olea Sphere V2.3 Manufacturer: Olea Medical Cla… | 2013 |
| * | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSummary page 6…essentially identical to the architecture used by the following FDA cleared predicate devices: 2) 510(k) Number: K121434 Trade Name: Software Syngo MR D13A for the Magnetom Systems Aer… | 2012 |
| * | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSummary page 6…er: 21 CFR 892.1000 Product Code: LNH Classification: Class II 3) 510(k) Number: K130749 Trade Name: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vas… | 2013 |
| * | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Summary page 7…ditional 510(k) – Olea Sphere V3.0 Page 7-2 4) 510(k) Number: K141977 Trade Name: Magnetom Aera with Software Syngo MR E11A, Magn… | 2014 |
What descends from it? (17)
See all 1711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223532 | Olea S.I.A. Neurovascular V1.0 | 2023 | 1 |
| K211059 | CereFlow™ V1.2 | 2023 | 1 |
| K212565 | CoverScan v1 | 2022 | 1 |
| K203582 | QUIBIM Precision Prostate (qp-Prostate) | 2021 | 1 |
| K182716 | Brain Perfusion (BP) application | 2019 | 1 |
| K170580 | Carestream Vue PACS | 2017 | 1 |
| K243681 | Neuro Insight V1.0 | 2025 | 0 |
| K223091 | CT Perfusion V1.0 | 2023 | 0 |
| K230552 | MR DWI/FLAIR Measurement V1.0 | 2023 | 0 |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | 2023 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 18 of the 47 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K223532 (Olea Medical, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K132095.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere V3.0 provides both viewing and analysis…
Read the full statement (305 words)
Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DW]I) / Fiber Tracking Module and a Dynamic Analysis Module (e.g. dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g. over time with or without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as:
Perfusion Module — the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Permeability Module — the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.
Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.
Relaxometry Module — the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.
Metabolic Module — the calculation of parameters related to the fat fraction based on a MR technique using opposed-phase imaging.
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/K152602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152602: Olea Sphere V3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152602
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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