510(k) K221624
K221624 is an FDA 510(k) premarket notification submitted by Avenda Health, Inc. for the device "Avenda Health AI Prostate Cancer Planning Software". The FDA issued a decision of Substantially Equivalent on November 22, 2022. The device falls under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2060. Avenda Health, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2022
- Date Received
- June 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Device Class
- Class II
- Regulation Number
- 892.2060
- Review Panel
- RA
- Submission Type
Assist users in characterizing lesions identified on acquired medical images