510(k) · Cleared
ClearedMylab 90 Ultrasound Imaging System, Model 6100
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 Jul 20, 2005 as substantially equivalent to K982444 (Biosound Esaote, Inc., 1998) and 5 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1995. 64 later devices descend from it.
- Decided
- Jul 20, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K944485 (1995). 20 ancestors in all, the oldest K934139 (1995). 64 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 5 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 4 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 3 generations backK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
- 2 generations backK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
- 1 generation backK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
- This deviceK051837 Mylab 90 Ultrasound Imaging System, Model 6100Esaote, 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 · cites it directly · 57 of its ownK081794 Model 7340 Ultrasound SystemEsaote, S.p.A. · 2008
- Descendant · cites it directly · 53 of its ownK081386 Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · Recalled
- Descendant · 2 generations on · 51 of its ownK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- 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 · cites it directly57descendants
- K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A. · 2008 · cites it directly53descendants
- K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A. · 2009 · 2 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −5 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −4 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −3 | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging… | Biosound Esaote, Inc. | 2002 | — |
| −2 | K040596 | Ultrasound Imaging System, Model 7300 | Esaote, S.p.A. | 2004 | 4 |
| −1 | K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote, S.p.A. | 2005 | 1 |
| 0 (this device) | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100 | 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 | — |
| +1 | K081794 | Model 7340 Ultrasound System | Esaote, S.p.A. | 2008 | — |
| +1 | K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | Esaote, S.p.A. | 2008 | 2 |
| +2 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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? (6)
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…9OIYN; 901Y0 807.92(a)(3) Predicate Device(s) Esaote, S.p.A. 7250 Ultrasound Imaging System K982444 Esaote, S.p.A. 7350 Ultrasound Imaging System K050326 Esaote, S.p.A. Technos… | 1998 |
| * | K050326 | 7350 Ultrasound Imaging System, Model 7350Summary page 1…ce(s) Esaote, S.p.A. 7250 Ultrasound Imaging System K982444 Esaote, S.p.A. 7350 Ultrasound Imaging System K050326 Esaote, S.p.A. Technos Ultrasound Imaging System K990360 Esaote, S.p.A. Technos… | 2005 |
| * | K990360 | AU6Summary page 1…982444 Esaote, S.p.A. 7350 Ultrasound Imaging System K050326 Esaote, S.p.A. Technos Ultrasound Imaging System K990360 Esaote, S.p.A. Technos Ultrasound Imaging System K014168 Esaote, S.p.A. Technos… | 1999 |
| * | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Summary page 1…050326 Esaote, S.p.A. Technos Ultrasound Imaging System K990360 Esaote, S.p.A. Technos Ultrasound Imaging System K014168 Esaote, S.p.A. Technos Ultrasound Imaging System K023255 Phillips, Inc. iU22 U… | 2002 |
| * | K023255 | Technos MP, Model AU6Summary page 1…990360 Esaote, S.p.A. Technos Ultrasound Imaging System K014168 Esaote, S.p.A. Technos Ultrasound Imaging System K023255 Phillips, Inc. iU22 Ultrasound Imaging System K042540… | 2003 |
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 1…K014168 Esaote, S.p.A. Technos Ultrasound Imaging System K023255 Phillips, Inc. iU22 Ultrasound Imaging System K042540 7 5 0(k) Summar\ NyI… | 2004 |
What descends from it? (64)
See all 645 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K081794 | Model 7340 Ultrasound System | 2008 | 57 |
| K081386 | Model 6150 (MYLAB70) and Model 6100 (MYLAB90) | 2008 | 53 |
| K100931 | Mylabtwice, Model 6200 | 2010 | 46 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K060827 (Esaote, S.p.A., 2006) has gone furthest, with 62 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 MyLab90 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, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.
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/K051837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051837: Mylab 90 Ultrasound Imaging System, Model 6100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051837
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