Sectra Workstation IDS7

Primary DI
07350092810012
Brand
Sectra Workstation IDS7
Company
Sectra AB
Model
18.2
Device description
Sectra Workstation is intended for the display and manipulation of medical images and other related medical information. It can show images from different sources and interface with various image storage and printing devices using DICOM and similar interface standards.Areas of application include, e.g., radiology, mammography, pathology, orthopedic preoperative planning and postoperative follow-up.Lossy compressed mammographic images are not intended for diagnostic review. For primary diagnosis, post-process DICOM “for presentation” images should be used.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081469000SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2Sectra Imtec AB2008-06-12LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350092810012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350092810012073500928100127350092810012

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4613235200regulatoryaffairs@sectra.com

Regulatory Flags#

DUNS number
354117848
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350092810654Sectra Workstation 28.12026-05-12
07350092810685Sectra Digital Pathology Module5.02026-05-12
07350092810678Sectra Orthopedic Package19.22026-03-05
07350092810616Sectra Workstation 27.22025-10-27
07350092810609Sectra Orthopedic Package19.12025-07-17
07350092810593Sectra Digital Pathology Module4.22025-04-09
07350092810579Sectra Workstation 27.12025-04-08
07350092810562Sectra Orthopedic Package18.22025-01-12
07350092810524Sectra Digital Pathology Module4.12024-10-11
07350092810531Sectra Workstation 26.22024-10-11
07350092810555Sectra Orthopedic Package18.12024-08-21
07350092810517Sectra Workstation26.12024-06-04
07350092810500Sectra Digital Pathology Module4.02024-05-07
07350092810494Sectra Orthopedic Package17.22024-01-02
07350092810487Sectra Digital Pathology Module3.42023-11-13
07350092810470Sectra Workstation25.22023-11-12
07350092810449Sectra Workstation25.12023-06-21
07350092810456Sectra Digital Pathology Module3.32023-06-21
07350092810463Sectra Orthopedic Package17.12023-06-21
07350092810395Sectra Calibration Unit22022-11-07

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