510(k) · Cleared
ClearedAdvantis Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advantis Medical Imaging Single Member P.C. · LLZ System, Image Processing, Radiological
Cleared on Mar 1, 2023 as substantially equivalent to K202808 (Advantis Medical Imaging Single Member P.C., 2021) and 1 other predicate after a 154-day review. Its family tree reaches back 15 generations to 1997. 5 of the 200 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 1, 2023
- Review
- 154 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K971684 (1997). 199 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 5 of the 200 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations between
- 3 generations backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- 2 generations backK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- This deviceK222975 Advantis PlatformAdvantis Medical Imaging Single Member P.C. · 2023
Show all 15 generations
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 13 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 11 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 10 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 9 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 8 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 7 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 6 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 5 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 4 generations backK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- 3 generations backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- 2 generations backK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- This deviceK222975 Advantis PlatformAdvantis Medical Imaging Single Member P.C. · 2023
Class I recalls in this family
- K153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma…3 generations back · 2016
- K121434 Software Syngo MR D13A for the Magnetom Systems…3 generations back · 2012
- K101347 Magnetom Aera; Magnetom Skyra3 generations back · 2010
- K151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit…4 generations back · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −14 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −13 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −12 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −11 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −10 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −9 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −8 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −7 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −6 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −5 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −4 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −3 | K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −2 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −1 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| 0 (this device) | K222975 | Advantis Platform | Advantis Medical Imaging Single Member P.C. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 13 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 19 | 0 |
| 2002 | 15 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 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.
5 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? (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 |
|---|---|---|---|
| * | K202808 | Brainance MDSummary page 4…age management and processing system Classification Regulation: 21 CFR 892.2050 Class: I Panel : Radiology Product Code : LLZ Predicate Device Primary Predicate 1 : K202808, Brainance MD, manufactured by Advantis Medical Imaging Single Member P.C. Primary Predicate 2 : K180336, syngo.MR Applications,… | 2021 |
| * | K180336 | syngo.MR ApplicationsSummary page 4…ogy Product Code : LLZ Predicate Device Primary Predicate 1 : K202808, Brainance MD, manufactured by Advantis Medical Imaging Single Member P.C. Primary Predicate 2 : K180336, syngo.MR Applications, manufactured by Siemens Medical Solutions USA, Inc. Reference Device Name : K092954, CADstream Version 5… | 2018 |
| † | K092954 | Cadstream Version 5 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations back · ◆ 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
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of 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 26 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 48 of the 199 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Advantis Platform provides analysis and visualization capabilities of dynamic MRI data of the brain and prostate, presenting the derived properties and parameters in a clinically useful context.
Advantis Platform is intended as a general medical image management and processing system. Advantis Platform is intended to be used by trained healthcare professionals and provides information that, in a clinical setting, may assist in the interpretation of brain and prostate MR studies of adult population.
Diagnosis should not be made solely based on the analysis performed using Advantis Platform.
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/K222975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222975: Advantis Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222975
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