Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Avenda Health AI Prostate Cancer Planning Software

K-Number: K221624 · 2022-11-22

ApplicantAvenda Health, Inc.
Decision Date2022-11-22
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Avenda Health AI Prostate Cancer Planning Software is a medical device manufactured by Avenda Health, Inc.. It received FDA 510(k) clearance on 2022-11-22 under approval number K221624. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avenda Health AI Prostate Cancer Planning Software?

Avenda Health AI Prostate Cancer Planning Software is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Avenda Health, Inc.. The 510(k) number is K221624.

When was Avenda Health AI Prostate Cancer Planning Software approved by the FDA?

Avenda Health AI Prostate Cancer Planning Software received FDA 510(k) clearance on 2022-11-22, under approval number K221624.

What company makes Avenda Health AI Prostate Cancer Planning Software?

Avenda Health AI Prostate Cancer Planning Software is manufactured by Avenda Health, Inc..

What is the FDA product code for Avenda Health AI Prostate Cancer Planning Software?

The FDA product code for Avenda Health AI Prostate Cancer Planning Software is POK.

Related Clinical Trials

NCT06626022 Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging. RECRUITING NCT05804318 Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer RECRUITING NCT06929481 Screening With a DNA Blood Test to Address Colorectal Cancer Inequities ACTIVE_NOT_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07594002 Comparing Acupuncture vs. Sham Acupuncture for the Management of Hot Flashes in Prostate Cancer Patients Receiving Hormone Therapy NOT_YET_RECRUITING NCT07609225 Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026)

Other Devices by Avenda Health, Inc.

K201687Avenda Health Treatment System

Related Devices (Code: POK)

DEN170022QuantXQuantitative Insights, Inc. K190442Koios DS for BreastKoios Medical, Inc. K201555EchoGo ProUltromics, Ltd. K200760Rapid ASPECTSIschemaview, Inc. K212616Koios DSKoios Medical, Inc. K202300Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑