510(k) · Cleared
ClearedEvis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 17, 2025 as substantially equivalent to K203128 (Olympus Medical Systems Corp., 2020) after a 66-day review. Its family tree reaches back 15 generations to 1995. 1 of the 128 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 17, 2025
- Review
- 66 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K935595 (1995). 127 ancestors in all, the oldest K812810 (1981). No later device cites it as a predicate yet. 1 of the 128 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK121564 Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012
- 2 generations backK130058 Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp. · 2013
- 1 generation backK203128 Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus…Olympus Medical Systems Corp. · 2020
- This deviceK243502 Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation · 2025
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK093466 HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision…Hitachi Medical Systems America, Inc. · 2010 · Recalled
- 3 generations backK121564 Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012
- 2 generations backK130058 Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp. · 2013
- 1 generation backK203128 Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus…Olympus Medical Systems Corp. · 2020
- This deviceK243502 Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation · 2025
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…5 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K093466 | HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| −3 | K121564 | Endoscopic Ultrasound Center EU-Y0006 | Olympus Medical Systems Corp. | 2012 | — |
| −2 | K130058 | Endoscopic Ultrasound Center EU-Y0008 | Olympus Medical Systems Corp. | 2013 | — |
| −1 | K203128 | Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic… | Olympus Medical Systems Corp. | 2020 | — |
| 0 (this device) | K243502 | Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3) | Olympus Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 9 | 1 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K203128 | Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Summary page 6…Table 1. Table 1: Predicate Device Device name 510(k) Submitter 510(k) No. OLYMPUS EU-ME2 Premier Plus OLYMPUS MEDICAL SYSTEMS CORP. K203128 A Reference device (shown in Table 2) was included in the submission to support the Subject device Strain Ratio, Strain Histogra… | 2020 |
| † | K183456 | Aloka Arietta 850 | 2019 |
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 32 of the 127 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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?
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe real-time ultrasound images and is indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, intraluminal ultrasound for airways, tracheobronchial tree, trans-rectal, trans-urethral, and trans-esophageal (non-cardiac). <Modes of Operation> B mode, PWD…
Read the full statement (109 words)
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe real-time ultrasound images and is indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, intraluminal ultrasound for airways, tracheobronchial tree, trans-rectal, trans-urethral, and trans-esophageal (non-cardiac).
<Modes of Operation>
B mode, PWD (Pulsed Wave Doppler) mode, Color Doppler (including Power Doppler) mode, combinations of each mode of operation (B mode, PWD mode, Color Doppler mode) and Other (Harmonic Imaging, Elastography and Shear Wave Speed Measurement [Shear Wave Quantification]).
<Operator Qualifications>
Appropriately trained healthcare professionals.
<Device Use Settings>
Hospital or Patient care facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243502 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243502: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243502
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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