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510(k) Data Aggregation
K Number
K211227Device Name
HTx Disposable Hysteroscope System
Manufacturer
AcuVu Inc.
Date Cleared
2021-09-15
(145 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
AcuVu Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HTx disposable hysteroscope system is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
Device Description
The HTx Disposable Hysteroscope System is a single use hysteroscope endoscope intended for gynecology procedure applications. It includes a disposable cannula module, a reusable imaging system, a medical grade display and optional software for processing patient management. The disposable cannula contains a miniature complementary metal-oxide-semiconductor (CMOS) camera, a light-emitting diode (LED) illumination module, and a channel for fluid and device. The cannula connects directly to the image system via an image cable. The cannula also contains three (3) buttons for video recording, picture taking, and light-emitting diode (LED) brightness control. The image system connects to a medical grade display module via DVI port. The external patient management software runs on an external PC that connects with the image system via LAN cable.
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K Number
K180096Device Name
GDT-1000 System
Manufacturer
AcuVu Inc.
Date Cleared
2018-04-16
(90 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
AcuVu Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Acu Vu GDT-1000 System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
Device Description
The AcuVu GDT-1000 System is a single-use hysteroscope intended for gynecologic procedures. It includes a disposable cannula module, a reusable handle module, a tower mounted swivel base medical grade touch screen PC for processing system software, operating the graphical user interface, performing image and video capture and display, as well as report creation for a session.
The Handle Module is reusable. Its distal end has a connecting interface, with self-locking mechanism, for attaching and detaching the disposable cannula. Its proximal end has a USB connection interface and cable length of 2.9 m for attaching the handle to the Display Module.
The disposable cannula module family includes two models. One for the purpose of diagnosis, and the other one for operative/therapeutic procedure. The diagnosis cannula has one water channel with two luers at proximal end, for water inflow and outflow. The therapeutic operative cannula has one shared working channel with three lures at proximal end, for water inflow and outflow, as well as for small operative instrument access. The disposable single-use cannula contains a miniature camera module and a pair of light- emitting diode (LED) illumination module at the tip. The cannula connects to the handle through an electrical connector for image data transfer, camera control and power supply. The disposable cannula has overall length of 300 mm to 350 mm.
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