PHASED ARRAY TRANSDUCER

GUDID 04987670102721

CANON INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 04987670102721
• NIH Device Record Key: 4474a606-f211-4bae-aa38-de62dd7b5a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHASED ARRAY TRANSDUCER
• Version Model Number: PSU-60ST
• Company DUNS: 690549662
• Company Name: CANON INC.
• 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	04987670102721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173962

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-09
• Device Publish Date: 2026-03-01

On-Brand Devices [PHASED ARRAY TRANSDUCER]

• 04987670102769: PSU-30ST
• 04987670102721: PSU-60ST