xx.xxHexaVue - HexaVue Focus Integration System with Surgical Light Control
2025-10-17
Black Diamond Video, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008776287 | 3008776287 | Black Diamond Video, Inc. | 1 | N | 2026-01-01 | 503 Canal Blvd Richmond CA US 94804 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00724995198459 | FREE5 - The HD FREE5 Camera System allows surgeons to view and record the surgical site from virtually any orientation or angle. | +1(800)548-4873 | xx@xx.xx |
| 00724995198497 | HexaVue - The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals. | +1(800)548-4873 | xx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 279798 | 1643186663 | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | FGB | 2023-07-25 |
| 279798 | 2038477098 | K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | FGB | 2023-02-17 |
| 279798 | 1025938273 | K211347 | Uretero1 Ureteroscope System | FGB | 2021-11-23 |
| 279798 | 1116434404 | K133413 | IDSS SLC | FTA | 2014-01-07 |
| 279798 | 1439792890 | ||||
| 279798 | 1702483660 |
Product Codes Associated With Registrations#
GUDID#
HexaVue - HexaVue Focus In-Light Camera Control Feature
2025-10-17
HexaVue - HexaVue IP Surgical Light Control Feature
2024-02-08
HexaVue - HexaVue IP In-Light Camera Control Feature
2024-02-08
HexaVue - The HexaVue Surgical Camera Control OR Integration software module allows the remote control of surgical camera.
2021-03-31
HexaVue - The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals.
2020-09-04
FREE5 - The HD FREE5 Camera System allows surgeons to view and record the surgical site from virtually any orientation or angle.
2021-04-23
Uretero1 - The Uretero1 Standard Deflection Disposable Ureteroscope is a single use flexible ureteroscope that is used to visualize and perform various diagnostic and therapeutic procedures in the urinary tract.
2022-06-10
Uretero1 - The Uretero1 Reverse Deflection Disposable Ureteroscope is a single use flexible ureteroscope that is used to visualize and perform various diagnostic and therapeutic procedures in the urinary tract.
2022-06-10
Vision1 - The Vision1 Imaging Console and Display System is used exclusively with the Uretero1 Ureteroscope System.
2022-06-10
NA - The IDSS Integration System with Surgical Camera Control is an integrated audio-visual system which combines monitors, medical imaging devices, lights, music, and cameras.
2021-04-23
Harmony iQ - The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt reaction to procedure events.
2021-04-23
Harmony iQ - The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events.
2021-04-23
NA - The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.
2019-02-28
NA - The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.
2017-06-06
Vividimage W 4K - The Vividimage W 65-inch 4K Medical Grade Display is designed to meet surgery room viewing needs of healthcare professionals through the delivery of exceptionally crisp, bright, and realistic images.
2022-08-19
Vividimage 4K - The Vividimage 31-inch 4K Surgical Display is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-04-23
Vividimage 4K - The Vividimage 31-inch 4K Surgical Display is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-04-23
Vividimage D HD - The Vividimage D 27-inch HD Surgical Display is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-03-31
Vividimage D HD - The Vividimage D 27-inch HD Surgical Display, without power, is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-03-31
Vividimage 4K - The Vividimage 31-inch 4K Surgical Display, Generator 2, is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-03-31
Vividimage 4K - The Vividimage 31-inch 4K Surgical Display, Generator 2, without power is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-03-31
Vividimage W - The Vividimage W 42-inch Wall Display is designed to meet surgery room viewing needs of healthcare professionals through the delivery of exceptionally crisp, bright, and realistic images.
2021-03-31
Vividimage W - The Vividimage W 50-inch Hospital Graded Display is designed to meet surgery room viewing needs of healthcare professionals through the delivery of exceptionally crisp, bright, and realistic images.
2021-03-31
Vividimage W - The Vividimage W 55-inch Medical Grade Display is designed to meet surgery room viewing needs of healthcare professionals through the delivery of exceptionally crisp, bright, and realistic images.
2021-03-31
Vividimage 4K - The Vividimage 27-inch 4K Surgical Monitor is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-03-31
Vividimage 4K - The Vividimage 27-inch 4K Surgical Monitor, without power is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
2021-03-31
Vividimage W 4K - The Vividimage W 65-inch 4K Medical Grade Display is designed to meet surgery room viewing needs of healthcare professionals through the delivery of exceptionally crisp, bright, and realistic images.
2021-03-31
NA - OR Integration software module Version 6 that allows the remote control of surgical lights during a surgical procedure.
2016-09-02