510(k) · Cleared
ClearedMyLabSix CrystaLine
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 Oct 14, 2016 as substantially equivalent to K161359 (Esaote, S.p.A., 2016) and 1 other predicate after a 60-day review. Its family tree reaches back 17 generations to 1995. 1 of the 169 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 14, 2016
- Review
- 60 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K935595 (1995). 168 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet. 1 of the 169 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- 2 generations backK142077 MylabgammaEsaote, S.p.A. · 2014 · Recalled
- 1 generation backK161359 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A. · 2016 · Recalled
- This deviceK162290 MyLabSix CrystaLineEsaote, S.p.A. · 2016
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 13 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 8 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 7 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091009 MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY…Esaote, S.p.A. · 2009
- 5 generations backK110688 MylabgoldEsaote · 2011 · Recalled
- 4 generations backK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- 3 generations backK141486 Mylabsix Ultrasound SystemEsaote Europe B.V. · 2014
- 2 generations backK142077 MylabgammaEsaote, S.p.A. · 2014 · Recalled
- 1 generation backK161359 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A. · 2016 · Recalled
- This deviceK162290 MyLabSix CrystaLineEsaote, S.p.A. · 2016
Class I recalls in this family
- K070106 VV Fluoro 3D4 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −13 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −11 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −7 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY… | Esaote, S.p.A. | 2009 | — |
| −5 | K110688 | Mylabgold | Esaote | 2011 | 1 |
| −4 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| −3 | K141486 | Mylabsix Ultrasound System | Esaote Europe B.V. | 2014 | — |
| −2 | K142077 | Mylabgamma | Esaote, S.p.A. | 2014 | 3 |
| −1 | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | Esaote, S.p.A. | 2016 | 5 |
| 0 (this device) | K162290 | MyLabSix CrystaLine | Esaote, S.p.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 14 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 15 | 0 |
| 2004 | 17 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 1 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemSummary page 6…P P P P P P P P: 5 The SI2C41 probe is already cleared via K161359 N: New indication; P: Previously cleared by FDA; E:Added under Appendix E [1] Small Organs includes Breast, Thyroid and Testicl… | 2016 |
| * | K141486 | Mylabsix Ultrasound SystemSummary page 30…) Device Owner Primary K161359 6400 – MyLabSeven Esaote S.p.A. Reference K141486 6420 – MyLabSix Esaote Europe B.V. Additional substantial equivalence information is provided in the substa… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 41 of the 168 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K161359.
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. 2016, 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?
Esaote’s Model 6425 Ultrasound System is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
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/K162290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162290: MyLabSix CrystaLine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162290
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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