Device
Sectra Workstation is a software-only device intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical infor...
Manufacturer
Sectra AB
Sectra AB
Model: 28.1
DI: 07350092810654
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Sectra Workstation is a software-only device intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information.
Sectra Workstation can show images from different sources and can interface with various image storage and printing devices.
Sectra Workstation is intended for use with Sectra Core for storage and retrieval of medical images and other related medical information.
Areas of application include e.g. radiology, cardiology and ophthalmology.
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.
Sectra UniView 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.
Typical users of Sectra Workstation are trained medical professionals such as physicians, radiologists, nurses, medical technicians and assistants.
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6c796897-d1a8-4198-bee1-1080bb98c253
Distribution Status:
In Commercial Distribution
DUNS Number:
354117848
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07350092810654
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40943
Name: Radiology picture archiving and communication system workstation
Definition:
A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K081469
Supplement Number:
000