510(k) · Cleared
ClearedLogic Hd camera head green, System green
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corporation · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jun 14, 2022 as substantially equivalent to K182606 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2018) and 3 other predicates after a 284-day review. Its family tree reaches back 18 generations to 1994.
- Decided
- Jun 14, 2022
- Review
- 284 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K930667 (1994). 99 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 18 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 14 generations between
- 3 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 2 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 1 generation backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- This deviceK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
Show all 18 generations
- Root · 18 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 17 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 16 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 15 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 14 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 13 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 12 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 11 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 10 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 9 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 8 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 7 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 6 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 5 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 4 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 3 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 2 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 1 generation backK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- This deviceK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −17 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −16 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −15 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −14 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −13 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −12 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −11 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −10 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −9 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −8 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −7 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −6 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −5 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −4 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −3 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −2 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −1 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018 | — |
| 0 (this device) | K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 9 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K182606 | PINPOINT Endoscopic Fluorescence Imaging SystemSummary page 16…redicate Device Table 1: List of predicate devices Name of Predicate Device: PINPOINT Endoscopic Fluorescence Imaging System (PC9000) 510(k) Number: K182606 Regulatory Class: II Product Code: GCJ, IZI Manufacturer: Novadaq Technologies ULC (now a part of S… | 2018 |
| * | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Summary page 16…f GmbH The predicate has not been subject to a design related recall. Name of Predicate Device: Logic HD Camera Controller 510(k) Number : K200617 Regulatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH The predicate has… | 2020 |
| * | K180583 | Logic 4K Camera Controller, Logic 4K Camera HeadSummary page 16…rd Wolf GmbH The predicate has not been subject to a design related recall. Name of Predicate Device: Logic 4K Camera Head 510(k) Number : K180583 Regulatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH The predicate has… | 2018 |
| * | K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…Summary page 16…bH The predicate has not been subject to a design related recall. Name of Predicate Device: Panoview Ultra telescopes 10mm 510(k) Number : K203226 Regulatory Class: II Product Code: GCM / GCJ /HET Manufacturer: Richard Wolf GmbH The pr… | 2021 |
| * | — | Light Source LED 2.1 80W Named without a submission number | |
| * | — | Fiber Light Cable Ø 5MM TL 2.3M / 3M / 3.5M Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 26 of the 99 ancestors have a recall of any class.
- 11 other devices also cite its predicate K182606.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography. System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to…
Read the full statement (1,040 words)
Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope 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 or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with System green 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 of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes
ICG light sources
The products are used for providing white light and near-infrared light for diagnostic and therapeutic application, specifically in endoscopy.
The Light source LED green ENDOLIGHT can be used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
• Minimally invasive surgery.
• Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
• Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), ICG light sources can be used with System green to perform:
• Intraoperative fluorescence angiography.
• Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), ICG light sources can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The Light source LED green ENDOLIGHT is not intended for standalone use for biliary duct visualization.
Light cable
The products are used to transmit light in the visible spectral range from the light source to the application-specific instrument set.
Fiber Light Cables are used to provide real time endoscopic imaging using standard endoscopic visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
• Minimally invasive surgery.
• Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
• Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), fiber light cables can be used with System green to perform:
• Intraoperative fluorescence angiography.
• Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), fiber light cables can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Light cables are not intended for standalone use for biliary duct visualization.
Adapter for light cable
The products are used to connect light guides to light sources or endoscopes.
Camera Controller
The Logic HD Camera Controller 552510x and the Logic 4K Camera Controller 5525301 have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions.
The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
The Logic HD Camera Controller and the Logic 4K Camera Controller can be used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
• Minimally invasive surgery.
• Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
• Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), Camera Controllers can be used with System green to perform:
• Intraoperative fluorescence angiography.
• Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), Camera Controllers can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Camera Controllers are not intended for standalone use for biliary duct visualization.
The Logic HD camera head green is used to provide real time endoscopic imaging using standard endoscope visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
• Minimally invasive surgery.
• Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
• Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), Logic HD camera head green can be used with System green to perform:
• Intraoperative fluorescence angiography.
• Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), Logic HD camera head green can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The Logic HD camera head green is not intended for standalone use for biliary duct visualization.
PANOVIEW ULTRA Telescopes are used to provide real time endoscopic imaging using standard endoscopic visible light and near-infrared fluorescence imaging, this enables surgeons to perform:
• Minimally invasive surgery.
• Visual assessments of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
• Intraoperative cholangiography.
Upon intravenous administration of TRADENAME (ICG drug product), PANOVIEW ULTRA Telescopes can be used with System green to perform:
• Intraoperative fluorescence angiography.
• Fluorescence imaging of biliary ducts, and when indicated during intraoperative cholangiography.
Upon interstitial administration of TRADENAME (ICG drug product), PANOVIEW ULTRA Telescopes can be used with System green to perform:
• Intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
PANOVIEW ULTRA Telescopes are not intended for standalone use for biliary duct visualization
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212808: Logic Hd camera head green, System green.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212808
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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