510(k) · Cleared
Recalled · Class II · 20147350 Ultrasound Imaging System, Model 7350
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 28, 2005 as substantially equivalent to K982444 (Biosound Esaote, Inc., 1998) and 2 other predicates after a 19-day review. Its family tree reaches back 5 generations to 1995. 66 later devices descend from it. It has been recalled once.
- Decided
- Feb 28, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K944485 (1995). 10 ancestors in all. 66 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 4 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 3 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 2 generations backK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
- 1 generation backK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
- This deviceK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005
- Descendant · cites it directly · 64 of its ownK051837 Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005
- Descendant · cites it directly · 64 of its ownK051308 Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005
- Descendant · cites it directly · 62 of its ownK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
- Descendant · cites it directly · 60 of its ownK052805 MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A. · 2005
- Descendant · 2 generations on · 57 of its ownK081794 Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005 · cites it directly64descendants
- K051308Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005 · cites it directly64descendants
- K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A. · 2006 · cites it directly62descendants
- K052805MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A. · 2005 · cites it directly60descendants
- K081794Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008 · 2 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −4 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −3 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −2 | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging… | Biosound Esaote, Inc. | 2002 | — |
| −1 | K040596 | Ultrasound Imaging System, Model 7300 | Esaote, S.p.A. | 2004 | 4 |
| 0 (this device) | K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote, S.p.A. | 2005 | — |
| +1 | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100 | Esaote, S.p.A. | 2005 | — |
| +1 | K051308 | Mylab 70 Ultrasound Imaging System | Esaote, S.p.A. | 2005 | — |
| +1 | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006 | — |
| +1 | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 | Esaote, S.p.A. | 2005 | — |
| +2 | K081794 | Model 7340 Ultrasound System | Esaote, S.p.A. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K982444 | 7250 Ultrasound Imaging SystemSummary page 1…ber: 9OIYN; 90IYO 807.92(a)(3) Predicate Device(s) Esaote, S.p.A. 7250 Ultrasound Imaging K982444 System Esaote, S.p.A. 7250 Ultrasound Imaging K994369… | 1998 |
| * | K994369 | 7250 (MEGAS)Summary page 1…7250 Ultrasound Imaging K982444 System Esaote, S.p.A. 7250 Ultrasound Imaging K994369 System Esaote, S.p.A. 7300 Ultrasound Imaging K040596… | 2000 |
| * | K040596 | Ultrasound Imaging System, Model 7300Summary page 1…7250 Ultrasound Imaging K994369 System Esaote, S.p.A. 7300 Ultrasound Imaging K040596 System… | 2004 |
What descends from it? (66)
See all 665 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051837 | Mylab 90 Ultrasound Imaging System, Model 6100 | 2005 | 64 |
| K051308 | Mylab 70 Ultrasound Imaging System | 2005 | 64 |
| K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | 2006 | 62 |
| K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 | 2005 | 60 |
| K111302 | Mylabseven, Mylabalpha | 2011 | 24 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2014 | Class II | Z-2167-2014 | Software design | Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K051837 (Esaote, S.p.A., 2005) has gone furthest, with 64 descendants of its own.
- 4 other devices also cite its predicate K982444.
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.
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?
Esaote's Model 7350 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
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/K050326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050326: 7350 Ultrasound Imaging System, Model 7350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050326
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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