510(k) · Cleared
ClearedModification to Viewmate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ep Medsystems · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 11, 2008 as substantially equivalent to K031066 (Ep Medsystems, 2003) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 2003. 133 later devices descend from it.
- Decided
- Mar 11, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K031066 (2003). 133 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK031066 Viewmate Ultrasound Imaging SystemEp Medsystems · 2003
- 1 generation backK071028 Viewmate SystemEp Medsystems · 2007
- This deviceK073709 Modification to Viewmate SystemEp Medsystems · 2008
- Descendant · cites it directly · 132 of its ownK101091 Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010
- Descendant · 2 generations on · 98 of its ownK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- Descendant · 3 generations on · 96 of its ownK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010 · cites it directly132descendants
- K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on98descendants
- K123622AcusonSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on96descendants
- K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on74descendants
- K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · 4 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031066 | Viewmate Ultrasound Imaging System | Ep Medsystems | 2003 | — |
| −1 | K071028 | Viewmate System | Ep Medsystems | 2007 | — |
| 0 (this device) | K073709 | Modification to Viewmate System | Ep Medsystems | 2008 | — |
| +1 | K101091 | Z.One Ultra Ultrasound System | Zonare Medical Systems, Inc. | 2010 | — |
| +2 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +3 | K123622 | Acuson | Siemens Medical Solutions USA, Inc. | 2012 | 13 |
| +3 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| +4 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 10 | 0 |
| 2015 | 5 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 10 | 0 |
| 2022 | 13 | 0 |
| 2023 | 10 | 0 |
| 2024 | 11 | 0 |
| 2025 | 13 | 0 |
| 2026 | 5 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K031066 | Viewmate Ultrasound Imaging SystemSummary page 2…atients to visualize cardiac structures and blood flow within the heart Note: A copy of the original Diagnostic Ultrasound Indications for Use Form (K031066), which is not affected by this notification, is provided in Appendix 5. 8. Device Description 8.1. The purpose of this sub… | 2003 |
| * | K071028 | Viewmate SystemSummary page 2…first cleared for US marketing on October 17, 2003 (K031066). Clearance to market a modification to the ViewFlex® catheter was received on May 1,2007 (K071028) On August 18, 2006 EPMedSystems' ViewFlex® catheter was cleared for US marketing with Philips Medical Systems'… | 2007 |
What descends from it? (133)
See all 1331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101091 | Z.One Ultra Ultrasound System | 2010 | 132 |
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 5 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101091 (Zonare Medical Systems, Inc., 2010) has gone furthest, with 132 descendants of its own.
- 4 other devices also cite its predicate K031066.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073709 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073709: Modification to Viewmate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073709
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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