510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193054Substantially Equivalent

Sectra Digital Pathology Module

Sectra AB, Linköping, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193054 is the FDA 510(k) clearance record for Sectra Digital Pathology Module, a class II device, cleared for Sectra AB on under FDA product code QKQ (Digital Pathology Image Viewing And Management Software). FDA's definition for product code QKQ reads: "Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an...". FDA records list 5 510(k) clearances for Sectra AB, from to . As of , FDA records show no recalls naming K193054.

Clearance record

Decision date
Received
(151 days to decision)
Product code
QKQ Digital Pathology Image Viewing And Management Software
Regulation
21 CFR 864.3700
Device class
Class II
Review panel
Pathology
Applicant
Sectra AB Teknikringen 20, Linköping, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QKQ

Trailing 12 months
4 clearances under product code QKQ in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QKQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20262
September 20260
October 20260