MAXIO

GUDID 08908002051063

MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer.

PERFINT HEALTHCARE PRIVATE LIMITED

Robotic surgical navigation system

• Primary Device ID: 08908002051063
• NIH Device Record Key: 920f35fe-c343-4284-a884-5268a61af4a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXIO
• Version Model Number: V2
• Company DUNS: 915787310
• Company Name: PERFINT HEALTHCARE PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908002051063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132108

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2026-03-19
• Device Publish Date: 2018-05-04