510(k) · Cleared
Recalled · Class II · 2023Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound 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 Jun 17, 2010 as substantially equivalent to K011314 (Aloka Co., Ltd., 2001) and 1 other predicate after a 230-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jun 17, 2010
- Review
- 230 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954022 (1996). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- 3 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- 2 generations backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
- 1 generation backK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
- This deviceK093395 Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II…Olympus Medical Systems Corporation · 2010
- Descendant · cites it directly · 0 of its ownK232518 EndoSound Vision System; EVSEndosound, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232518EndoSound Vision System; EVSEndosound, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| −3 | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| −2 | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | Aloka Co. Ltd USA | 2003 | — |
| −1 | K043196 | Aloka SSD-Alpha 10 Ultrasound System | Aloka Co., Ltd. | 2004 | — |
| 0 (this device) | K093395 | Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound… | Olympus Medical Systems Corporation | 2010 | — |
| +1 | K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K011314 | Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound SystemSummary page 7…onic Echo Imaging System 876.1500 Endoscope and Accessories - II ITX/ IYN/ KOG/ NWB/ IYO Subject device Predicate devices Name Control number GF-UCT180 GF-UC140P-AL5 K011314 EVIS EXERA Il ULTRASOUND | ULTRASONIC GASTROVIDEQSCOPE GASTROVIDEOSCOPE _ SSD-a 10 ALOKA SSD-a 10 ULTRASOUND K043196 SYSTEM 4 De… | 2001 |
| * | K043196 | Aloka SSD-Alpha 10 Ultrasound SystemSummary page 7…devices Name Control number GF-UCT180 GF-UC140P-AL5 K011314 EVIS EXERA Il ULTRASOUND | ULTRASONIC GASTROVIDEQSCOPE GASTROVIDEOSCOPE _ SSD-a 10 ALOKA SSD-a 10 ULTRASOUND K043196 SYSTEM 4 Device Description OLYMPUS GF-UCT180 EVIS EXERA Il ULTRASOUND GASTRO VIDEOSCOPE have been designed to be used with the… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232518 | EndoSound Vision System; EVS | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0333-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Oct 16, 2020 | Class II | Z-0500-2021 | Device Design | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections. |
| Dec 17, 2018 | Class II | Z-1007-2019 | Under Investigation by firm | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. |
| Aug 21, 2015 | Class II | Z-2818-2015 | Device Design | Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K232518 (Endosound, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011314.
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. 2010, 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?
This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.
This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
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/K093395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093395: Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound Gastrovideoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093395
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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