Sectra AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sectra AB” (first 2000, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 69 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 151 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 265 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sectra AB took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| PSY | Whole Slide Imaging System | 1 | 1 |
| QKQ | Digital Pathology Image Viewing And Management Software | 1 | 1 |
Review panels
Most recent Sectra AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232208 | Sectra Digital Pathology Module (Version 3.3) | PSY | 2024-04-16 | 265 |
| K193054 | Sectra Digital Pathology Module | QKQ | 2020-03-31 | 151 |
| K034059 | SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE | LLZ | 2004-03-09 | 69 |
| K033088 | SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 | LLZ | 2003-10-29 | 30 |
| K001140 | IDS5 IMAGE DISPLAY SYSTEM | LLZ | 2000-05-03 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Sectra AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sectra Imtec AB (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sectra AB?
FDA lists 5 510(k) clearances under the applicant name “Sectra AB” (first 2000, latest 2024), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sectra AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sectra AB is 69 days.
Which FDA product codes appear under Sectra AB?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); PSY (Whole Slide Imaging System, 1); QKQ (Digital Pathology Image Viewing And Management Software, 1).
Next steps
- See all 5 Sectra AB clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Sectra AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.