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

FDA 510(k)

VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67

K-Number: K053520 · 2006-04-11

ApplicantTripath Imaging, Inc.
Decision Date2006-04-11
Product CodeNQN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 is the device name listed in this FDA 510(k) record. The listed applicant is Tripath Imaging, Inc.. It received FDA 510(k) clearance on 2006-04-11 under 510(k) number K053520. The device is classified under product code NQN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67?

VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 is a medical device that received FDA 510(k) clearance on 2006-04-11. The listed applicant is Tripath Imaging, Inc.. The 510(k) number is K053520.

When did VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 receive FDA 510(k) clearance?

VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 received FDA 510(k) clearance on 2006-04-11, under 510(k) number K053520.

Who is the listed applicant for VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67?

The FDA 510(k) record lists Tripath Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67?

The FDA product code for VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 is NQN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tripath Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062428VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIASK051282VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEUK050012VENTANA IMAGE ANALYSIS SYSTEM

Related Devices (Code: NQN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130515VIRTUOSO SYSTEM FOR IHC ER (SPI)Ventana Medical Systems, Inc.K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.K122143VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERVentana Medical Systems, Inc.K111872VIRTUOSO SYSTEM FOR IHC P53 (DO-7)Ventana Medical Systems, Inc.K111869VIRTUOSO SYSTEM FOR IHC PR (IE2)Ventana Medical Systems, Inc.K092333PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67Bioimagene, Inc.

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.

↑