Data / Medical devices / Sweden / Sectra AB
Sectra AB: FDA-registered device maker in LINKOPING Ostergotland, Sweden, 3 510(k) clearances
Sectra AB is registered with the FDA (registration 9615992) in LINKOPING Ostergotland, Sweden. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 31, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615992
- FEI number
- 3001104292
- Address
- Teknikringen 20, LINKOPING Ostergotland, Sweden, 58330
- Owner or operator
- SECTRA AB (9026103)
- Roles
- Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- Sectra Calibration Unit, Sectra Digital Pathology Module, Sectra Orthopedic Package, Sectra Workstation, Sectra Workstation IDS5, Sectra Workstation IDS7, Sectra Workstation UniView
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Pathology Image Viewing And Management Software | QKQ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 31, 2020 | K193054 | Sectra Digital Pathology Module | QKQ | Substantially Equivalent | Sectra AB | accessdata.fda.gov |
| June 12, 2008 | K081469 | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 | LLZ | Substantially Equivalent | Sectra Imtec AB | accessdata.fda.gov |
| October 2, 2003 | K031590 | SECTRA ORTHOPEDIC PACKAGE | LLZ | Substantially Equivalent | Sectra-Imtec AB | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Digital Pathology Image Viewing And Management Software
Updated March 31, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.