# K212808: Logic Hd camera head green, System green

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: Jun 14, 2022 after 284 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K930667 (1994). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182606: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2018) Summary page 16.
- K200617: Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525, Richard Wolf Medical Instruments Corporation (2020) Summary page 16.
- K180583: Logic 4K Camera Controller, Logic 4K Camera Head, Richard Wolf Medical Instruments Corporation (2018) Summary page 16.
- K203226: Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL 305MM, Telescope 0 O 10MM WL 440MM / Telescope 30 O 10MM WL 440MM / Telescope 50 O 10MM WL 440MM, Richard Wolf Medical Instruments Corporation (2021) Summary page 16.
- (no number) Light Source LED 2.1 80W: named in the summary without a submission number
- (no number) Fiber Light Cable Ø 5MM TL 2.3M / 3M / 3.5M: named in the summary without a submission number

## Indications for use
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

Source page: https://510kreport.com/device/K212808
Methodology: https://510kreport.com/methodology