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FDA 510(k)

OptraSCAN System

K-Number: K260755 · 2026-07-02

ApplicantOptrascan, Inc.
Decision Date2026-07-02
Product CodeNOT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OptraSCAN System is the device name listed in this FDA 510(k) record. The listed applicant is Optrascan, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K260755. 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 OptraSCAN System?

OptraSCAN System is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Optrascan, Inc.. The 510(k) number is K260755.

When did OptraSCAN System receive FDA 510(k) clearance?

OptraSCAN System received FDA 510(k) clearance on 2026-07-02, under 510(k) number K260755.

Who is the listed applicant for OptraSCAN System?

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

What is the FDA product code for OptraSCAN System?

The FDA product code for OptraSCAN System 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.

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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.

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 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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