PHASED ARRAY TRANSDUCER

GUDID 04987670104862

CANON MEDICAL SYSTEMS CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 04987670104862
• NIH Device Record Key: 52797709-e5ba-440a-a5aa-0f6258e1eea6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHASED ARRAY TRANSDUCER
• Version Model Number: PSI-28VX
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• 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: true
• 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	04987670104862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223017

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: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [PHASED ARRAY TRANSDUCER]

• 04987670004483: PHASED ARRAY TRANSDUCER
• 04987670004476: PHASED ARRAY TRANSDUCER
• 04987670004377: PHASED ARRAY TRANSDUCER
• 04987670003356: PHASED ARRAY TRANSDUCER
• 04987670003349: PHASED ARRAY TRANSDUCER
• 04987670003332: PHASED ARRAY TRANSDUCER
• 04987670002953: PHASED ARRAY TRANSDUCER
• 04987670002946: PHASED ARRAY TRANSDUCER
• 04987670002823: PHASED ARRAY TRANSDUCER
• 04987670002816: PHASED ARRAY TRANSDUCER
• 04987670001291: PHASED ARRAY TRANSDUCER
• 04987670001284: PHASED ARRAY TRANSDUCER
• 04987670001277: PHASED ARRAY TRANSDUCER
• 04987670001260: PHASED ARRAY TRANSDUCER
• 04987670001253: PHASED ARRAY TRANSDUCER
• 04987670001246: PHASED ARRAY TRANSDUCER
• 04987670001239: PHASED ARRAY TRANSDUCER
• 04987670001161: PHASED ARRAY TRANSDUCER
• 04987670001154: PHASED ARRAY TRANSDUCER
• 04987670001147: PHASED ARRAY TRANSDUCER
• 04987670001130: PHASED ARRAY TRANSDUCER
• 04987670001123: PHASED ARRAY TRANSDUCER
• 04987670001116: PHASED ARRAY TRANSDUCER
• 04987670001109: PHASED ARRAY TRANSDUCER
• 04987670104862: PSI-28VX
• 04987670103742: PST-65BT
• 04987670103551: PST-28BT
• 04987670103124: PSI-50VX
• 04987670103117: PSI-40VX
• 04987670102547: PSI-30VX