Identity
- Trade Name
- Sectra Workstation IDS7 FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 18.2 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350092810012 FDA UDI
- 510(k) Number
- K081469 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology picture archiving and communication system workstation
Sectra Workstation IDS7 by Sectra AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology picture archiving and communication system workstation.
- WorkstationOne™ — Three Palm Software · Class II
- OTOPLAN — CAScination AG · Class II
- Nio Color 2MP LED — Barco, Inc. · Class II
- RamSoft — Ramsoft Inc · Class II
- Aline Ablation Intelligence — Mirada Medical, Ltd. · Class II
- CHILI PACS — CHILI GmbH · Class II
- Nio Color 2MP — Barco, Inc. · Class II
- RamSoft — Ramsoft Inc · Class II
Cleared under the same submission
K081469 also covers:
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
- Sectra Workstation — Sectra AB
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sectra AB
Sources (1)
- FDA UDI c8c7190a-91bc-4e22-9756-04bbcfcdf33d 35 fields · synced May 30, 2026