Sectra Imtec AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sectra Imtec AB” (first 2005, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 | 1 |
Review panels
- Radiology (5)
Most recent Sectra Imtec AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110025 | SECTRA MICRODOSE MAMMOGRAPHY | MUE | 2011-04-28 | 115 |
| K081469 | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 | LLZ | 2008-06-12 | 16 |
| K063093 | SECTRA WORKSTATION, VERSION 11.1 | LLZ | 2006-11-07 | 28 |
| K051315 | MODIFICATION TO: SECTRA IDS5 WORKSTATION | LLZ | 2005-06-15 | 26 |
| K050196 | SECTRA IDS5 WORKSTATION | LLZ | 2005-02-24 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Sectra Imtec 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 AB (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sectra Imtec AB?
FDA lists 5 510(k) clearances under the applicant name “Sectra Imtec AB” (first 2005, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sectra Imtec AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sectra Imtec AB is 28 days.
Which FDA product codes appear under Sectra Imtec AB?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); MUE (Full Field Digital, System, X-Ray, Mammographic, 1).
Next steps
- See all 5 Sectra Imtec AB clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Sectra Imtec 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.