510(k) · Cleared
ClearedM-VU Cad Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vucomp, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 9, 2006 as substantially equivalent to K031132 (Eastman Kodak Company, 2003) after a 44-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 9, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913475 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 4 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 3 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- 2 generations backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
- 1 generation backK031132 Consultiva Case Input Station, Model Cis-1Eastman Kodak Company · 2003
- This deviceK061160 M-VU Cad StationVucomp, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −4 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −3 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| −2 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| −1 | K031132 | Consultiva Case Input Station, Model Cis-1 | Eastman Kodak Company | 2003 | — |
| 0 (this device) | K061160 | M-VU Cad Station | Vucomp, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K031132 | Consultiva Case Input Station, Model Cis-1 | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The M-VuTM CAD Station is intended to support the acquisition and storage of medical images for subsequent digital analysis and processing. The medical imagery can be obtained from film format (digitized by a commercial FDA-cleared medical digitizer) or digital format transmitted via a standard DICOM network interface. The CAD Station can print case information and can connect over a Local Area Network and interface with the M-Vu Viewer Station. The CAD…
Read the full statement (131 words)
The M-VuTM CAD Station is intended to support the acquisition and storage of medical images for subsequent digital analysis and processing. The medical imagery can be obtained from film format (digitized by a commercial FDA-cleared medical digitizer) or digital format transmitted via a standard DICOM network interface. The CAD Station can print case information and can connect over a Local Area Network and interface with the M-Vu Viewer Station. The CAD Station is intended for use by a technician under the supervision of a medical professional.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061160 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061160: M-VU Cad Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061160
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