Clearance Summary
Roche Digital Pathology Dx received FDA 510(k) clearance under submission number K242783, sponsored by Ventana Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2024-12-17.
- Submission: K242783
- Applicant / Sponsor: Ventana Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2024-12-17
Classification & Regulation
This clearance is catalogued under FDA product code PSY and 21 CFR 864.3700, within the Pathology review panel as a Class II device.