510(k) · Cleared
ClearedVideo System Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · NTN Led Light Source
Cleared on Dec 14, 2012 as substantially equivalent to K112680 (Olympus Medical Systems Corporation, 2012) after an 88-day review. Its family tree reaches back 9 generations to 1993. 3 of the 50 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.
- Decided
- Dec 14, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- NTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931154 (1993). 30 ancestors in all, the oldest K843084 (1985). 19 later devices descend from it, 3 citing it directly. 3 of the 50 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- This deviceK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- Descendant · cites it directly · 12 of its ownK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- Descendant · cites it directly · 4 of its ownK193202 EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK213606 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 5 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 4 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- This deviceK122831 Video System CenterOlympus Medical Systems Corp. · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 19 · See all- K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017 · cites it directly12descendants
- K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020 · 2 generations on6descendants
- K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation · 2019 · cites it directly4descendants
- K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022 · 2 generations on3descendants
- K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −5 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −4 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −1 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| 0 (this device) | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| +1 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| +2 | K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020 | — |
| +1 | K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019 | 6 |
| +2 | K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022 | — |
| +3 | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K112680 | Evis Exera Iii Video SystemSummary page 2…e Information Model name Applicant 510(k) No. OLYMPUS CV-190 VIDEO OLYMPUS MEDICAL K112680 SYSTEM CENTER SYSTEMS CORP. _______ OLYMPUS CLV-190 XENON OLYMPUS MEDICAL… | 2012 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 17 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K163675 (Fujifilm Medical System U.S.A., Inc., 2017) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K112680.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NTN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NTN
Too few NTN 510(k)s in any year since 2007 to give a median.
Recalls per year · NTN
No recall names NTN since 2007.
Adverse event reports per year · NTN
42in 2025
MAUDE reports naming product code NTN, 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 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 47 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This video system center is intended to be used with OLYMPUS video converter, camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122831: Video System Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122831
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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