510(k) DEN240068
DEN240068 is an FDA 510(k) premarket notification submitted by Artera, Inc. for the device "ArteraAI Prostate". The FDA issued a decision of De Novo Granted on Jul 31, 2025. The device falls under product code SFH (Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis), a Class II device regulated under 21 CFR 864.3755. Artera, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jul 31, 2025
- Date Received
- Nov 25, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis
- Device Class
- Class II
- Regulation Number
- 864.3755
- Review Panel
- PA
- Submission Type
A pathology software algorithm device analyzing digital images for prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.