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FDA 510(k)

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

K-Number: K111543 · 2011-10-12

ApplicantVentana Medical Systems, Inc.
Decision Date2011-10-12
Product CodeNOT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-10-12 under 510(k) number K111543. 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 VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)?

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) is a medical device that received FDA 510(k) clearance on 2011-10-12. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K111543.

When did VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) receive FDA 510(k) clearance?

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) received FDA 510(k) clearance on 2011-10-12, under 510(k) number K111543.

Who is the listed applicant for VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)?

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

What is the FDA product code for VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)?

The FDA product code for VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) 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 Ventana Medical Systems, 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.

K242783Roche Digital Pathology DxK232879Roche Digital Pathology Dx (VENTANA DP 200)K212176CINtec HistologyK172471VENTANA CD30 (Ber-H2) RxDx AssayK130515VIRTUOSO SYSTEM FOR IHC ER (SPI)K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

View all 44 devices →

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.K080564SCANSCOPE XT SYSTEMAperio TechnologiesK080910PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITSBioimagene, 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.

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