Sectra Workstation

GUDID 07350092810210

Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, and cardiology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used. Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast.

Sectra AB

Radiology picture archiving and communication system workstation

• Primary Device ID: 07350092810210
• NIH Device Record Key: 6766df56-7229-41ce-8b38-222d4b22cf8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Workstation
• Version Model Number: 22.1
• 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	07350092810210 [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: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-19

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