Sectra Digital Pathology Module
K-Number: K193054 · 2020-03-31
ApplicantSectra AB
Decision Date2020-03-31
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
Sectra Digital Pathology Module is a medical device manufactured by Sectra AB. It received FDA 510(k) clearance on 2020-03-31 under approval number K193054. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sectra Digital Pathology Module?
Sectra Digital Pathology Module is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Sectra AB. The 510(k) number is K193054.
When was Sectra Digital Pathology Module approved by the FDA?
Sectra Digital Pathology Module received FDA 510(k) clearance on 2020-03-31, under approval number K193054.
What company makes Sectra Digital Pathology Module?
Sectra Digital Pathology Module is manufactured by Sectra AB.
What is the FDA product code for Sectra Digital Pathology Module?
The FDA product code for Sectra Digital Pathology Module is QKQ.
Related PubMed Literature
PMID: 41476571
Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report.
Journal of pathology informatics (2026)
PMID: 41437380
Applications of artificial intelligence in non-small cell lung cancer: from precision diagnosis to personalized prognosis and therapy.
Journal of translational medicine (2025)
Other Devices by Sectra AB
Related Devices (Code: QKQ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.