NA

Basic Information

• Brand Name: NA
• Primary DI: 06974813831363
• Version / Model: Sinobot X1
• Company Name: Sinovation (Beijing) Medical Technology Co., Ltd
• Labeler DUNS: 560671783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-31
• Public Version: 1
• Public Version Date: 2023-09-08
• Public Version Status: New
• Public Device Record Key: 92abd40b-fdc5-47fd-9a18-1fc4a8626a11

Device Description

Sinobot X1 Robotized image-guided interactive surgical equipment (including robotic arm, Display screen, Computer and software, Foot switch) 120 V - 60 Hz

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974813831363	GS1

Premarket Submissions

Submission Number	Supplement Number
K220072	000