510(k) K242244
K242244 is an FDA 510(k) premarket notification submitted by Lumea, Inc. for the device "Viewer+". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code QKQ (Digital Pathology Image Viewing And Management Software), a Class II device regulated under 21 CFR 864.3700.
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.