Sectra Workstation
- Primary DI
- 07350092810470
- Brand
- Sectra Workstation
- Company
- Sectra AB
- Model
- 25.2
- Device description
- 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, cardiology and ophthalmology.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.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.
- Published
- 2023-11-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K081469 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07350092810470 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07350092810470 | 07350092810470 | 7350092810470 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +4613235200 | regulatoryaffairs@sectra.com |
Regulatory Flags#
- DUNS number
- 354117848
- Device count
- 1
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07350092810722 | Sectra Orthopedic Package | 20.1 | 2026-09-06 | |
| 07350092810654 | Sectra Workstation | 28.1 | 2026-05-12 | |
| 07350092810685 | Sectra Digital Pathology Module | 5.0 | 2026-05-12 | |
| 07350092810678 | Sectra Orthopedic Package | 19.2 | 2026-03-05 | |
| 07350092810616 | Sectra Workstation | 27.2 | 2025-10-27 | |
| 07350092810609 | Sectra Orthopedic Package | 19.1 | 2025-07-17 | |
| 07350092810593 | Sectra Digital Pathology Module | 4.2 | 2025-04-09 | |
| 07350092810579 | Sectra Workstation | 27.1 | 2025-04-08 | |
| 07350092810562 | Sectra Orthopedic Package | 18.2 | 2025-01-12 | |
| 07350092810524 | Sectra Digital Pathology Module | 4.1 | 2024-10-11 | |
| 07350092810531 | Sectra Workstation | 26.2 | 2024-10-11 | |
| 07350092810555 | Sectra Orthopedic Package | 18.1 | 2024-08-21 | |
| 07350092810517 | Sectra Workstation | 26.1 | 2024-06-04 | |
| 07350092810500 | Sectra Digital Pathology Module | 4.0 | 2024-05-07 | |
| 07350092810494 | Sectra Orthopedic Package | 17.2 | 2024-01-02 | |
| 07350092810487 | Sectra Digital Pathology Module | 3.4 | 2023-11-13 | |
| 07350092810449 | Sectra Workstation | 25.1 | 2023-06-21 | |
| 07350092810456 | Sectra Digital Pathology Module | 3.3 | 2023-06-21 | |
| 07350092810463 | Sectra Orthopedic Package | 17.1 | 2023-06-21 | |
| 07350092810395 | Sectra Calibration Unit | 2 | 2022-11-07 |
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