Geniant Cranial

Basic Information

• Brand Name: Geniant Cranial
• Primary DI: 08800050902666
• Version / Model: KY-PWS-0030-B
• Company Name: KOH YOUNG TECHNOLOGY INC.
• Labeler DUNS: 695406977
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-20
• Public Version: 1
• Public Version Date: 2025-02-28
• Public Version Status: New
• Public Device Record Key: 79109273-9e49-4990-9733-44eb35d79f2e

Device Description

Planning Workstation (US)

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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
45195	Stereotactic surgery system workstation	A freestanding image processing device specifically designed to be networked with one or more stereotactic surgery systems. It typically does not contain the controls for the direct operation of the system, but rather is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the stereotactic system's operator console. It may be configured to provide the capability to further process, manipulate and/or view patient images and information collected from one or more systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800050902666	GS1

Premarket Submissions

Submission Number	Supplement Number
K241333	000