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FDA 510(k)

VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)

K-Number: K061613 · 2007-01-10

ApplicantTripath Imaging
Decision Date2007-01-10
Product CodeNQN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) is the device name listed in this FDA 510(k) record. The listed applicant is Tripath Imaging. It received FDA 510(k) clearance on 2007-01-10 under 510(k) number K061613. 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 - PATHWAY HER2 (4B5)?

VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) is a medical device that received FDA 510(k) clearance on 2007-01-10. The listed applicant is Tripath Imaging. The 510(k) number is K061613.

When did VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) receive FDA 510(k) clearance?

VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) received FDA 510(k) clearance on 2007-01-10, under 510(k) number K061613.

Who is the listed applicant for VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)?

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

What is the FDA product code for VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)?

The FDA product code for VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) is NQN.

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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

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

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