Planmed

GUDID 06430035430055

Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.

Planmed Oy

Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue Stationary mammographic x-ray system, analogue

• Primary Device ID: 06430035430055
• NIH Device Record Key: 1ae19494-ceb5-4673-a73b-b74f694f6379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmed
• Version Model Number: Sophie Classic
• Company DUNS: 459718193
• Company Name: Planmed Oy
• 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: true
• 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	06430035430055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013656

FDA Product Code

• IZH: System, X-Ray, Mammographic

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: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [Planmed]

• 06430035430079: Planmed Clarity is a mammographic x-ray unit intended for diagnosis of breast cancer
• 06430035430062: Planmed Verity is a CBCT x-ray scanner for the diagnosis of extremities and the head.
• 06430035430055: Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer.
• 06430035430024: Planmed Nuance Excel is a mammographic x-ray unit intended for diagnosis of breast cancer.