Sectra-Imtec AB: FDA clearances and approvals
Sectra-Imtec AB has 9 FDA 510(k) clearances (first 1996, latest 2004), across 4 product codes in 1 review panel. Median 510(k) review time: 58 days.
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 | 5 | 5 |
| LMB | Device, Digital Image Storage, Radiological | 2 | 2 |
| KGI | Densitometer, Bone | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (9)
Most recent Sectra-Imtec AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040376 | SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE | LLZ | 2004-05-04 | 77 |
| K033712 | MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 | LLZ | 2003-12-23 | 27 |
| K031590 | SECTRA ORTHOPEDIC PACKAGE | LLZ | 2003-10-02 | 134 |
| K021527 | SECTRA OSTEOPOROSIS PACKAGE | KGI | 2002-06-07 | 28 |
| K002936 | MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM | LLZ | 2000-10-17 | 26 |
| K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM | LMB | 1998-10-29 | 29 |
| K965161 | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) | LMD | 1997-03-12 | 79 |
| K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | LMB | 1996-10-25 | 58 |
| K961983 | TRS 2000 TELERADIOLOGY SYSTEM | LLZ | 1996-08-13 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Sectra-Imtec AB.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sectra-Imtec AB have?
Sectra-Imtec AB has 9 FDA 510(k) clearances (first 1996, latest 2004), across 4 product codes in 1 review panel.
How long does FDA take to clear Sectra-Imtec AB's 510(k)s?
The median time from FDA receipt to decision across Sectra-Imtec AB's cleared 510(k)s is 58 days.
What devices does Sectra-Imtec AB make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 5); LMB (Device, Digital Image Storage, Radiological, 2); KGI (Densitometer, Bone, 1).
Has Sectra-Imtec AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Sectra-Imtec AB. Related entities may recall under other names.
Next steps
- See all 9 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.