HTx Image Processing System

Basic Information

• Brand Name: HTx Image Processing System
• Primary DI: 06974880990017
• Version / Model: HTx1000
• Company Name: Suzhou AcuVu medical technology Co., Ltd.
• Labeler DUNS: 705464292
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-01
• Public Version: 1
• Public Version Date: 2022-04-11
• Public Version Status: New
• Public Device Record Key: 2d0b52c1-60d0-4e4b-b1a6-b468e2eadb62

Device Description

This is the control unit for the scopes. It stores images and videos on its hard drive. It allows users to modify settings such as white balance and zoom.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63256	Rigid video hysteroscope	An electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974880990017	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211227	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 35 – Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 55 Degrees Celsius