Sectra Workstation

GUDID 07350092810074

Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medica

Sectra AB

Radiology picture archiving and communication system workstation

• Primary Device ID: 07350092810074
• NIH Device Record Key: e9c76b53-d128-43ab-9ca0-2e07a01fc330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Workstation
• Version Model Number: 20.1
• Company DUNS: 354117848
• Company Name: Sectra AB
• 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: false
• 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

Customer Support Contacts

• Phone: +4613235200
• Email: regulatoryaffairs@sectra.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350092810074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081469

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

On-Brand Devices [Sectra Workstation]

• 07350092810159: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810098: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810074: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810067: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810050: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810036: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810234: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810210: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810265: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810326: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810357: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810371: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810418: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810449: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810470: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810517: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im
• 07350092810531: Sectra Workstation is intended for the display, manipulation and diagnostic review of medical im