510(k) K242244

Viewer+ by Lumea, Inc. — Product Code QKQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 14, 2025
Date Received: July 31, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Digital Pathology Image Viewing And Management Software
Device Class: Class II
Regulation Number: 864.3700
Review Panel: PA
Submission Type

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 aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Other clearances for product code QKQ

K243449 — INFINITT DPS (December 9, 2025)
K252762 — HALO AP Dx (November 25, 2025)
K243391 — AISight Dx (June 26, 2025)
K250968 — PathPresenter Clinical Viewer (June 20, 2025)
K250414 — CaloPix (May 14, 2025)
K241273 — FullFocus (January 9, 2025)
K240303 — MetaLite DX Digital Pathology Software (October 28, 2024)
K233126 — aetherSlide (May 30, 2024)
K212361 — Novo (August 11, 2022)
K210811 — Dynamyx Digital Pathology Software (March 1, 2022)