510(k) · Cleared
ClearedCoverScan v1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perspectum, Ltd. · LLZ System, Image Processing, Radiological
Cleared on May 19, 2022 as substantially equivalent to K152602 (Olea Medical, 2016) and 3 other predicates after a 279-day review. Its family tree reaches back 14 generations to 1997. 3 of the 65 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- May 19, 2022
- Review
- 279 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K971684 (1997). 63 ancestors in all, the oldest K896095 (1990). 1 later device descends from it, 1 citing it directly. 3 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations between
- 3 generations backK143020 LiverMultiScanMirada Medical, Ltd. · 2015
- 2 generations backK172685 LiverMultiScanPerspectum Diagnostics, Ltd. · 2017
- 1 generation backK190017 LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd. · 2019
- This deviceK212565 CoverScan v1Perspectum, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK230294 CoverScan (CoverScan v1.1)Perspectum · 2023
Show all 14 generations
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 13 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 12 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 10 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 9 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 8 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 7 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 6 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 5 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 4 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 3 generations backK143020 LiverMultiScanMirada Medical, Ltd. · 2015
- 2 generations backK172685 LiverMultiScanPerspectum Diagnostics, Ltd. · 2017
- 1 generation backK190017 LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd. · 2019
- This deviceK212565 CoverScan v1Perspectum, Ltd. · 2022
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K230294CoverScan (CoverScan v1.1)Perspectum · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −13 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −12 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −11 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −10 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −9 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −8 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −7 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −6 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −5 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −4 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −3 | K143020 | LiverMultiScan | Mirada Medical, Ltd. | 2015 | — |
| −2 | K172685 | LiverMultiScan | Perspectum Diagnostics, Ltd. | 2017 | — |
| −1 | K190017 | LiverMultiScan (LMSv3) | Perspectum Diagnostics, Ltd. | 2019 | — |
| 0 (this device) | K212565 | CoverScan v1 | Perspectum, Ltd. | 2022 | — |
| +1 | K230294 | CoverScan (CoverScan v1.1) | Perspectum | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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 |
|---|---|---|---|
| * | K152602 | Olea Sphere V3.0Summary page 4…edicate Device Device No. 2 No. 3 No. 4 510(k) number Not known K152602 K190017 K141480 K101342 Legal Manufacturer Perspectum Ltd. Olea Medical Perspe… | 2016 |
| * | K190017 | LiverMultiScan (LMSv3)Summary page 4…Device No. 2 No. 3 No. 4 510(k) number Not known K152602 K190017 K141480 K101342 Legal Manufacturer Perspectum Ltd. Olea Medical Perspectum Ltd. Circle… | 2019 |
| * | K141480 | CVI42Summary page 4…Device No. 2 No. 3 No. 4 510(k) number Not known K152602 K190017 K141480 K101342 Legal Manufacturer Perspectum Ltd. Olea Medical Perspectum Ltd. Circle Pixmeo Sa… | 2014 |
| * | K101342 | Osirix MDSummary page 4…Device No. 2 No. 3 No. 4 510(k) number Not known K152602 K190017 K141480 K101342 Legal Manufacturer Perspectum Ltd. Olea Medical Perspectum Ltd. Circle Pixmeo Sarl Owner/Operator… | 2010 |
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 |
|---|---|---|---|
| K230294 | CoverScan (CoverScan v1.1) | 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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 63 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K230294 (Perspectum, 2023) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K152602.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal…
Read the full statement (142 words)
CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (Ti, SR-Ti, cTI, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212565: CoverScan v1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212565
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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