Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Sectra AB and its 1 subsidiaries with 19 510(k) clearances. The most recent is a 510(k) clearance dated Apr 16, 2024: Sectra Digital Pathology Module (Version 3.3).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sectra AB and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 16, 2024 | Sectra Digital Pathology Module (Version 3.3)K232208 · PSY | 510(k) clearances |
| Mar 31, 2020 | Sectra Digital Pathology ModuleK193054 · QKQ | 510(k) clearances |
| Apr 28, 2011 | SECTRA MICRODOSE MAMMOGRAPHYK110025 · MUE | 510(k) clearances |
| Jun 12, 2008 | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2K081469 · LLZ | 510(k) clearances |
| Nov 7, 2006 | SECTRA WORKSTATION, VERSION 11.1K063093 · LLZ | 510(k) clearances |
| Jun 15, 2005 | MODIFICATION TO: SECTRA IDS5 WORKSTATIONK051315 · LLZ | 510(k) clearances |
| Feb 24, 2005 | SECTRA IDS5 WORKSTATIONK050196 · LLZ | 510(k) clearances |
| May 4, 2004 | SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGEK040376 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
