Sectra Digital Pathology Module— 510(k) K193054

Substantially Equivalent

Sectra AB

FDA 510(k) clearance K193054 for Sectra Digital Pathology Module, Substantially Equivalent on 2020-03-31. Applicant: Sectra AB. Device class: 2.

Clearance details

Applicant: Sectra AB
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2019-11-01
Decision date: 2020-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linköping, SE

Download summary PDF View on FDA.gov ↗

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More clearances from Sectra AB

K232208 — Sectra Digital Pathology Module (Version 3.3)2024-04-16
K034059 — SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE2004-03-09
K033088 — SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.12003-10-29
K001140 — IDS5 IMAGE DISPLAY SYSTEM2000-05-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.