510(k) K250414
K250414 is an FDA 510(k) premarket notification submitted by Tribun Health for the device "CaloPix". The FDA issued a decision of Substantially Equivalent on May 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
- May 14, 2025
- Date Received
- February 13, 2025
- 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.