510(k) · Cleared
ClearedOlympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope
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 Feb 8, 2007 as substantially equivalent to K043275 (Olympus Medical Systems Corporation, 2004) and 9 other predicates after a 58-day review. Its family tree reaches back 6 generations to 1989. 15 later devices descend from it.
- Decided
- Feb 8, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K894632 (1989). 52 ancestors in all, the oldest K812810 (1981). 15 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 5 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 4 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 3 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 2 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 1 generation backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- This deviceK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- Descendant · cites it directly · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK121564 Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012
- Descendant · 2 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 3 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 4 of its ownK130058 Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp. · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · cites it directly7descendants
- K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012 · cites it directly6descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on5descendants
- K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp. · 2013 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −5 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −4 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −3 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −2 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −1 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| 0 (this device) | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| +1 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| +1 | K121564 | Endoscopic Ultrasound Center EU-Y0006 | Olympus Medical Systems Corp. | 2012 | — |
| +2 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +3 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K130058 | Endoscopic Ultrasound Center EU-Y0008 | Olympus Medical Systems Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
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? (11)
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 |
|---|---|---|---|
| * | K043275 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterSummary page 13…80-1YN/90-IYO/S0-ITX/78-KOG 3 Predicate Device Information N Ultrasound System GASTROVIDEQSCOPE Subject device Predicate device Name Control : number XEU-M60A EU-M60 K043275 ENDOSCOPIC ULTRASOUND | EUS EXERA ENDOSCOPIC CENTER ULTRASOUND CENTER EU-C80 K010591 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENT… | 2004 |
| * | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterSummary page 13…TROVIDEQSCOPE Subject device Predicate device Name Control : number XEU-M60A EU-M60 K043275 ENDOSCOPIC ULTRASOUND | EUS EXERA ENDOSCOPIC CENTER ULTRASOUND CENTER EU-C80 K010591 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER W__Ultrasonic Gastrovideoscopes and Probes Subject device Predicate device Name Co… | 2001 |
| * | K944610 | Olympus Ultrasonic ProbesSummary page 13…0 K010591 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER W__Ultrasonic Gastrovideoscopes and Probes Subject device Predicate device Name Controf number UM-2R/3R UM-2R/3R K944610 ULTRASONIC PROBES ULTRASONIC PROBES K982323 K982610 UM-DP12/20-25R UM-2R/3R . Based ULTRASONIC PROBES ULTRASONIC PROBES upon K944… | 1995 |
| * | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseSummary page 13…SOUND CENTER W__Ultrasonic Gastrovideoscopes and Probes Subject device Predicate device Name Controf number UM-2R/3R UM-2R/3R K944610 ULTRASONIC PROBES ULTRASONIC PROBES K982323 K982610 UM-DP12/20-25R UM-2R/3R . Based ULTRASONIC PROBES ULTRASONIC PROBES upon K944610, K982323, K982610, { Olympus determined… | 1998 |
| * | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Summary page 13…NTER W__Ultrasonic Gastrovideoscopes and Probes Subject device Predicate device Name Controf number UM-2R/3R UM-2R/3R K944610 ULTRASONIC PROBES ULTRASONIC PROBES K982323 K982610 UM-DP12/20-25R UM-2R/3R . Based ULTRASONIC PROBES ULTRASONIC PROBES upon K944610, K982323, K982610, { Olympus determined that no… | 1998 |
| * | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary… Our OCR of the scanned summary read K871660, FDA’s number for Western Ragweed Allergen Disc (Incstar Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GF-UM130 ULTRASONIC GASTROVIDEOSCOPE”. | 1997 |
| * | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Summary page 13…n K944610, K982323, K982610, { Olympus determined that no 510(k) was required for device - changes. GF-UM130 GF-UM130- | K871660 ULTRASONIC ULTRASONIC GASTRCVIDEOSCOPE | K011886 GASTROVIDEQSCOPE GF-UM160 , GF-UM160 KD11886 EUS EXERA ULTRASONIC EUS EXERA ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE XGF-UM18… | 2001 |
| * | K051541 | GF-UE160-AL5 Ultrasound EndoscopeSummary page 13…EXERA ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE XGF-UM180 GF-UM160 This ULTRASONIC ULTRASONIC GASTROVIDEOSCOPE | submission GASTROVIDEOSCOPE GF-UE160-AL5 GF-UE160-AL5 K051541 ULTRASONIC ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE , GF-UC140P-AL5 GF-UC140P-ALS K011314 ULTRASONIC ULTRASONIC GASTROVIDEOSC… | 2005 |
| * | K011314 | Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound SystemSummary page 13…IC GASTROVIDEOSCOPE | submission GASTROVIDEOSCOPE GF-UE160-AL5 GF-UE160-AL5 K051541 ULTRASONIC ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE , GF-UC140P-AL5 GF-UC140P-ALS K011314 ULTRASONIC ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE GF-UCT140-ALS GF-UCT140-ALS ‘ K012080 ULTRASONIC ULTRASONIC GASTROVIDEOSC… | 2001 |
| * | K012080 | SSD-5000 Diagnostic Ultrasound SystemSummary page 13…ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE , GF-UC140P-AL5 GF-UC140P-ALS K011314 ULTRASONIC ULTRASONIC GASTROVIDEOSCOPE GASTROVIDEOSCOPE GF-UCT140-ALS GF-UCT140-ALS ‘ K012080 ULTRASONIC ULTRASONIC GASTROVIDEOSCOPE 4 Device Description The combination of the XEU-MB0CA Endoscopic Ultraso… | 2001 |
| * | — | GF-UM160 Ultrasonic Gastrovideoscope Named without a submission number |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 10 of the 52 ancestors have a recall of any class.
- Of its descendants, K092156 (Softscope Medical Technologies, Inc., 2009) has gone furthest, with 7 descendants of its own.
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. 2007, 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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow…
Read the full statement (117 words)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K063683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063683: Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063683
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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