510(k) · Cleared
Recalled · Class II · 2025Ashvins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicalcommunications GmbH · LLZ System, Image Processing, Radiological
Cleared on Feb 18, 2020 as substantially equivalent to K142750 (Visus Technology Transfer GmbH, 2015) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1997. It has been recalled once.
- Decided
- Feb 18, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K971684 (1997). 44 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- 2 generations backK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- 1 generation backK142750 JiveXVisus Technology Transfer GmbH · 2015
- This deviceK200132 AshvinsMedicalcommunications GmbH · 2020
Show all 10 generations
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 6 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 5 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 4 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 3 generations backK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- 2 generations backK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- 1 generation backK142750 JiveXVisus Technology Transfer GmbH · 2015
- This deviceK200132 AshvinsMedicalcommunications GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −9 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −8 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −7 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −6 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −5 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −4 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −3 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| −2 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
| −1 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| 0 (this device) | K200132 | Ashvins | Medicalcommunications GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K142750 | JiveXSummary page 5…Device Class: II Product Code: LLZ Product Code: NFJ 21 CFR 892.2050 21 CFR 892.2050 K142750 K122938 MedicalCommunications GmbH MCDOC-1419004256-26… | 2015 |
| * | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist MatchSummary page 5…Product Code: NFJ 21 CFR 892.2050 21 CFR 892.2050 K142750 K122938 MedicalCommunications GmbH MCDOC-1419004256-2672 Max-Jarecki-Str. 8, D-69115 Heidelberg Ver… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2025 | Class II | Z-2673-2025 | Software design | Potential that the measured value may be smaller than the actual area. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 16 of the 44 ancestors have a recall of any class.
- 1 other device also cites its predicate K142750.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information. Ashvins offers advanced image…
Read the full statement (137 words)
Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM “For Presentation” images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200132: Ashvins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200132
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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