Sectra AB
Shelton, CT, US
SECTRA AB appears in FDA device records in Shelton, CT. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Sectra AB between 2000 and 2024. The busiest year on record is 2000, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232208 | Sectra Digital Pathology Module (Version 3.3) | PSY | Substantially Equivalent | |
| K193054 | Sectra Digital Pathology Module | QKQ | Substantially Equivalent | |
| K034059 | SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE | LLZ | Substantially Equivalent | |
| K033088 | SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 | LLZ | Substantially Equivalent | |
| K001140 | IDS5 IMAGE DISPLAY SYSTEM | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615992 | 3001104292 | SECTRA AB | TEKNIKRINGEN 20, LINKOPING Ostergotland 58330 SE | 2026 | |
| 3004160000 | 3004160000 | Sectra Inc. | 1 Corporate Drive #400, Shelton, CT 06484 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain