Sectra Workstation IDS7

GUDID 07350092810012

Sectra Workstation is intended for the display and manipulation of medical images and other related medical information. It can show images from diff

Sectra AB

Radiology picture archiving and communication system workstation

• Primary Device ID: 07350092810012
• NIH Device Record Key: c8c7190a-91bc-4e22-9756-04bbcfcdf33d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Workstation IDS7
• Version Model Number: 18.2
• 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	07350092810012 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-21

Devices Manufactured by Sectra AB

• 07350092810524 - Sectra Digital Pathology Module: 2024-10-21 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital
• 07350092810531 - Sectra Workstation: 2024-10-21 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an
• 07350092810555 - Sectra Orthopedic Package: 2024-08-29 Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measure
• 07350092810517 - Sectra Workstation: 2024-06-12 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an
• 07350092810500 - Sectra Digital Pathology Module: 2024-05-15 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital
• 07350092810494 - Sectra Orthopedic Package: 2024-01-10 Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measure
• 07350092810487 - Sectra Digital Pathology Module: 2023-11-21 For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital
• 07350092810470 - Sectra Workstation: 2023-11-20 Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) an