PET-CT SCANNER

GUDID 04987670103810

This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.

CANON MEDICAL SYSTEMS CORPORATION

PET/CT system

• Primary Device ID: 04987670103810
• NIH Device Record Key: a4c6fff4-8314-4016-90d1-105b489a7cc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PET-CT SCANNER
• Version Model Number: PCD-1000A
• 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: 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	04987670103810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203314

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-14

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

• 04987670104374 - ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S: 2025-07-10
• 04987670103216 - CONVEX ARRAY TRANSDUCER: 2025-04-09
• 04987670100079 - CATHETERIZATION TABLE: 2025-03-21
• 04987670100345 - X-RAY FLAT PANEL DETECTOR: 2025-03-11
• 04987670104312 - X-RAY FLAT PANEL DETECTOR: 2025-03-11
• 04987670104121 - Aquilion Exceed LB: 2025-01-22
• 04987670105579 - Aquilion ONE: 2025-01-17
• 04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM: 2024-07-15