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510(k) K201005

FullFocus by Paige.Ai, Inc. — Product Code QKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
April 16, 2020
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 by Paige.Ai, Inc.

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  • K250968 — PathPresenter Clinical Viewer (June 20, 2025)
  • K250414 — CaloPix (May 14, 2025)
  • K242244 — Viewer+ (March 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)