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FDA 510(k)

PATHIAM IMAGING SOFTWARE FOR HER2/NEU

K-Number: K062756 · 2007-02-20

ApplicantBioimagene, Inc.
Decision Date2007-02-20
Product CodeNOT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PATHIAM IMAGING SOFTWARE FOR HER2/NEU is the device name listed in this FDA 510(k) record. The listed applicant is Bioimagene, Inc.. It received FDA 510(k) clearance on 2007-02-20 under 510(k) number K062756. The device is classified under product code NOT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHIAM IMAGING SOFTWARE FOR HER2/NEU?

PATHIAM IMAGING SOFTWARE FOR HER2/NEU is a medical device that received FDA 510(k) clearance on 2007-02-20. The listed applicant is Bioimagene, Inc.. The 510(k) number is K062756.

When did PATHIAM IMAGING SOFTWARE FOR HER2/NEU receive FDA 510(k) clearance?

PATHIAM IMAGING SOFTWARE FOR HER2/NEU received FDA 510(k) clearance on 2007-02-20, under 510(k) number K062756.

Who is the listed applicant for PATHIAM IMAGING SOFTWARE FOR HER2/NEU?

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

What is the FDA product code for PATHIAM IMAGING SOFTWARE FOR HER2/NEU?

The FDA product code for PATHIAM IMAGING SOFTWARE FOR HER2/NEU is NOT.

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 Bioimagene, 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.

K092333PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67K080910PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

Related Devices (Code: NOT)

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.

K260755OptraSCAN SystemOptrascan, Inc.K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.K121350VIRTUSO SYSTEM FOR IHC (DO-7)Ventana Medical Systems, Inc.K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.K080564SCANSCOPE XT SYSTEMAperio Technologies

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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