510(k) · Cleared
ClearedVISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · OWN Confocal Optical Imaging
Cleared on Nov 12, 2025 as substantially equivalent to K202925 (Karl Storz Endoscopy_America, Inc., 2020) and 1 other predicate after a 196-day review. Its family tree reaches back 19 generations to 1994. 3 of the 160 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 12, 2025
- Review
- 196 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K930667 (1994). 159 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet. 3 of the 160 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 15 generations between
- 3 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 2 generations backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- 1 generation backK202925 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. · 2020
- This deviceK251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)…Olympus Medical Systems Corp. · 2025
Show all 19 generations
- Root · 19 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 18 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 17 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 16 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 15 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 14 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 13 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 12 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 11 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 10 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 9 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 8 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 7 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 6 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 5 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 4 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 3 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 2 generations backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- 1 generation backK202925 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. · 2020
- This deviceK251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)…Olympus Medical Systems Corp. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −18 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −17 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −16 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −15 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −13 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −12 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −10 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −9 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −8 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −7 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −6 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −5 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −4 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −3 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −2 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018 | — |
| −1 | K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy_America, Inc. | 2020 | — |
| 0 (this device) | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE… | Olympus Medical Systems Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 6 | 1 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 10 | 0 |
| 1996 | 6 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 1 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 1 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 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.
3 devices in this family have 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 OWN device
- #1 K231854 1788 4K Camera System with Advanced Imaging…score 24.9 · 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 |
|---|---|---|---|
| * | K202925 | KARL STORZ ICG Imaging SystemSummary page 7…vice Device name 510(k) Submitter 510(k) No. Karl Storz ICG Imaging System Karl Storz K202925 Reference device Device name 510(k) Submitter 510(k) No. VISERA ELITE II Infr… | 2020 |
| * | K242067 | Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Summary page 7…The following subject devices of the OLYMPUS VISERA ELITE III Surgical Imaging System are identical to and unchanged from the VISERA ELITE III Surgical Imaging System (K242067): • VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model Number: OLYMPUS OTV-S700) – OLYMPUS OTV-S700 is a vid… | 2025 |
| † | K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video… | 2020 |
| † | K202646 | Visera Elite II Video System Center | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 4 generations back · ◆ in the 2006 ancestors bar of FIG. 16 Class I recalls
- 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
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 48 of the 159 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K202925.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWN
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWN
197in 2025
MAUDE reports naming product code OWN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 87 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 208 | 0 | 0 |
| 2015 | 5 | 163 | 0 | 1 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 5 | 87 | 0 | 12 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 7 | 81 | 0 | 59 |
| 2020 | 7 | 81 | 0 | 105 |
| 2021 | 4 | 104 | 0 | 312 |
| 2022 | 4 | 41 | 3 | 346 |
| 2023 | 6 | 69 | 0 | 164 |
| 2024 | 1 | — | 1 | 165 |
| 2025 | 3 | 196 | 0 | 197 |
| 2026 | 7 | 63 | 0 | — |
What is it indicated for?
The VISERA ELITE III Surgical Imaging System is intended to provide real-time visible and near infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, VISERA ELITE III Surgical Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major…
Read the full statement (295 words)
The VISERA ELITE III Surgical Imaging System is intended to provide real-time visible and near infrared fluorescence imaging.
Upon intravenous administration and use of ICG consistent with its approved label, VISERA ELITE III Surgical Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the VISERA ELITE III Surgical Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the VISERA ELITE III Surgical Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251336: VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251336
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